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
- 510(k)K102903Substantially equivalent (SESE) · 2010-10-20clearance family
Predicate lineage
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2024-06-14 | VAI | Voluntary action indicated | Pioneer Surgical Technology Inc. | 2 |
| 2024-06-14 | VAI | Voluntary action indicated | Pioneer Surgical Technology Inc. | 2 |
| 2023-05-11 | NAI | No action indicated | Pioneer Surgical Technology Inc. | 0 |
| 2023-05-11 | NAI | No action indicated | Pioneer Surgical Technology Inc. | 0 |
| 2017-03-28 | VAI | Voluntary action indicated | Pioneer Surgical Technology Inc. | 7 |
| 2017-03-28 | VAI | Voluntary action indicated | Pioneer Surgical Technology Inc. | 7 |
| 2016-06-23 | VAI | Voluntary action indicated | Pioneer Surgical Technology Inc. | 1 |
| 2016-06-23 | VAI | Voluntary action indicated | Pioneer Surgical Technology Inc. | 1 |
| 2014-07-11 | VAI | Voluntary action indicated | Pioneer Surgical Technology Inc. | 1 |
| 2014-07-11 | VAI | Voluntary action indicated | Pioneer Surgical Technology Inc. | 1 |
| 2012-03-28 | NAI | No action indicated | Pioneer Surgical Technology Inc. | 0 |
| 2012-03-28 | NAI | No action indicated | Pioneer Surgical Technology Inc. | 0 |
| 2010-12-21 | VAI | Voluntary action indicated | Pioneer Surgical Technology Inc. | 6 |
| 2010-12-21 | VAI | Voluntary action indicated | Pioneer Surgical Technology Inc. | 6 |
| 2010-08-03 | WL | Warning Letter | Pioneer Surgical Technology Inc. | — |
| 2010-08-03 | WL | Warning Letter | Pioneer Surgical Technology Inc. | — |
| 2010-04-22 | OAI | Official action indicated | Pioneer Surgical Technology Inc. | 10 |
| 2010-04-22 | OAI | Official action indicated | Pioneer Surgical Technology Inc. | 10 |
Similar devices
- TiLink-P Disposable Drill Guide Dilator Surgentec, LLC
- 3.3mm Screw Fastener Self Tapping 14mm Osteocentric Technologies, Inc.
- 3.3mm Screw Fastener Self Tapping 16mm Osteocentric Technologies, Inc.
- 3.3mm Screw Fastener Self Tapping 18mm Osteocentric Technologies, Inc.
- 3.3mm Screw Fastener Self Tapping 20mm Osteocentric Technologies, Inc.
- 4.0 x 22mm LOCKING BONE SCREW FASTENER ST Osteocentric Technologies, Inc.
- Biosteon® IntraLine® BIOCOMPOSITES LTD
- CORTICAL BONE SCREW 3.5mm x 16mm ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- CORTICAL BONE SCREW 3.5mm x 20mm ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- CORTICAL BONE SCREW 3.5mm x 24mm ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- CORTICAL BONE SCREW 3.5mm x 26mm ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- Container FOURNITURES HOSPITALIERES INDUSTRIE
Select up to two to place side-by-side with this device.