Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
No recalls linked.
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2011-10-14 | NAI | No action indicated | Interventional Spine Inc | 0 |
| 2011-02-04 | OAI | Official action indicated | Interventional Spine Inc | 5 |
Similar devices
- 10mm Narrow PPK Spacer Block Biomet Orthopedics, LLC
- 110mm DEPTH GAUGE Osteocentric Technologies, Inc.
- 12mm Narrow PPK Spacer Block Biomet Orthopedics, LLC
- 14mm Narrow PPK Spacer Block Biomet Orthopedics, LLC
- 16205-01050; 16205-01110; 60-025 Hankil Tech Medical Co., Ltd.
- 1mm PPK Resection Shim Biomet Orthopedics, LLC
- 2 IN 1 DRILL GUIDE Biomet Orthopedics, LLC
- 2.0/2.4 Depth Gage, 70MM SYMMETRY MEDICAL INC.
- 2.0MM DEPTH GAUGE Biomet Orthopedics, LLC
- 2.0MM DEPTH GAUGE Biomet Orthopedics, LLC
- 2.7mm Depth Gauge, Outer Sleeve Assembly 10-60mm ORTHOPEDIATRICS CORP.
- 2.7mm Depth Gauge, Scale Assembly 10-60mm ORTHOPEDIATRICS CORP.
Select up to two to place side-by-side with this device.