FDA Adverse Event
Malfunction
Summary report: N
SPDLNK 5.5 TRANS CNTR LONG 50-65MM
MDR report key: 1102123
·
Received August 7, 2008
Report
- Report Number
- 1649384-2008-00418
- Event Type
- Malfunction
- Date Received
- August 7, 2008
- Date of Event
- July 8, 2008
- Report Date
- August 7, 2008
- Manufacturer
- ABBOTT SPINE
- Product Code
- KWP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT WAS NOT EXPLANTED. EVALUATION IS PENDING.
Description of Event or Problem · 1
DURING SURGERY IN 2008, THE SALES REPRESENTATIVE REPORTED THAT THE SURGEON MALLETED THE SPEEDLINK IN PLACE WITH THE DIAMOND DRIVER. THE LEFT CAM WOULD NOT TURN COMPLETELY, BUT THE SURGEON FELT THE DEVICE WOULD HOLD SO IT WAS LEFT AS IT WAS. THERE WAS NO SURGICAL DELAY. THE MALFUNCTION HAS RESULTED IN INTERVENTION IN THE PAST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPDLNK 5.5 TRANS CNTR LONG 50-65MM | SPEEDLINK | KWP | ABBOTT SPINE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |