FDA Adverse Event
Injury
Summary report: N
SPDLNK 5.5 TRANS CNTR LONG 50-65MM
MDR report key: 1150236
·
Received September 3, 2008
Report
- Report Number
- 1649384-2008-00465
- Event Type
- Injury
- Date Received
- September 3, 2008
- Date of Event
- August 6, 2008
- Report Date
- September 3, 2008
- Manufacturer
- ABBOTT SPINE
- Product Code
- KWP
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE HISTORY RECORD REVIEW INDICATES THE PART MET SPECS. VISUAL EXAMINATION OF THE RETURNED PRODUCT FOUND THE CAM RETENTION FEATURE DISLODGED AND GALLED. THE EVIDENCE SUGGESTS THE SPEEDLINK MAY NOT HAVE BEEN LOOSENED IN THE PROPER ORDER OR A FAILURE TO USE THE TORQUE LIMITING DRIVER WHEN TIGHTENING THE CENTER SET SCREW PER THE SURGICAL TECHNIQUE.
Description of Event or Problem · 1
THE SALES REP REPORTED THAT IN 2008, THE PT WAS UNDERGOING FUSION SURGERY. THE LOCKING CAP ON THE SPEEDLINK DEVICE CAME LOOSE. IT DID NOT SLIP INTO THE SURGICAL WOUND. THE SPEEDLINK WAS REMOVED, AND ANOTHER SPEEDLINK WAS USED TO COMPLETE THE SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPDLNK 5.5 TRANS CNTR LONG 50-65MM | SPEEDLINK | KWP | ABBOTT SPINE | 29RB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |