K062842

Substantially Equivalent

TWIST DRILL

Applicant: Walter Lorenz Surgical, Inc.
Product code: HBE
Advisory panel: Neurology
Date received: 2006-09-22
Decision date: 2006-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Adverse events under product code HBE

product code HBE

Injury: 306
Malfunction: 7,175
Other: 1
Total: 7,482

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.