FDA Adverse Event
Injury
Summary report: N
DARCO HEADED SCREW
MDR report key: 2893407
·
Received December 21, 2012
Report
- Report Number
- 8043862-2012-00017
- Event Type
- Injury
- Date Received
- December 21, 2012
- Report Date
- December 20, 2012
- Manufacturer
- AAP IMPLANTATE AG
- Product Code
- HWC
- PMA / PMN Number
- K111316
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DISTRIBUTOR HAS SENT OUT THE REMOVED FRAGMENTS (B)(4) TO AAP. THEREFORE A FOLLOW-UP REPORT WILL BE SENT TO THE FDA AFTER INVESTIGATION OF THE SCREW FRAGMENTS. NEVERTHELESS IT SEEMS AT THE MOMENT THAT THE SCREW BROKE BECAUSE OF THE NON-UNION OF THE BONE WHICH IS A COMMON ROOT CAUSE FOR IMPLANT FAILURE.
Description of Event or Problem · 1
A CANNULATED SCREW 4.0 HAS BROKEN OFF INTO THE PT POST-OPERATIVELY. THE PRODUCTS WERE EXPLANTED EXCEPT ONE SCREW FRAGMENT WHICH WAS TOO DIFFICULT TO GET OUT WITHOUT UNNECESSARY DAMAGE TO SURROUNDING BONES. THE REASON FOR REVISION WAS NON-UNION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DARCO HEADED SCREW | BONE SCREW | HWC | AAP IMPLANTATE AG | SCN405002 | W008 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |