FDA Adverse Event
Injury
Summary report: N
CSLP VARABLE ANGLE LOCKING PLATE 4 LEVEL
MDR report key: 1241767
·
Received November 20, 2008
Report
- Report Number
- 2520274-2008-00108
- Event Type
- Injury
- Date Received
- November 20, 2008
- Report Date
- October 26, 2008
- Manufacturer
- SYNTHES (USA)
- Product Code
- HRS
- PMA / PMN Number
- NI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DATE OF MANUFACTURE CANNOT BE DETERMINED WITHOUT A LOT NUMBER. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER IS AVAILABLE.
Description of Event or Problem · 1
APPROX ONE MONTH AFTER IMPLANTATION, THREE SCREWS WERE FOUND TO BE BACKING OUT OF THE CSLP VARIABLE ANGLE LOCKING PLATE. SURGEON REMOVED THE SCREWS AND REVISED WITH RESCUE SCREWS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CSLP VARABLE ANGLE LOCKING PLATE 4 LEVEL | LOCKING PLATES | HRS | SYNTHES (USA) | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention | SCREWS |