FDA Adverse Event
Injury
Summary report: N
ANT-CER 1 LVL PLATE ASSY, 24MM
MDR report key: 1192113
·
Received October 7, 2008
Report
- Report Number
- 1649384-2008-00503
- Event Type
- Injury
- Date Received
- October 7, 2008
- Date of Event
- September 10, 2008
- Report Date
- October 7, 2008
- Manufacturer
- ABBOTT SPINE
- Product Code
- KWQ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE DEVICE HISTORY RECORD FOR THE PRODUCT FOUND THE IMPLANT MEETS SPECIFICATIONS. VISUAL EXAMINATION INDICATES NO RESTRICTOR PLATE SCREW ON THE RETURNED PLATE AND THE RATCHET TEETHES ON THE BASE SLIDER ARE WORN. FUNCTIONAL TESTING OF THE RATCHET FEATURE INDICATES RESISTANCE IN PULLING THE SLIDER FROM THE BASE SEGMENT, INDICATING THE RATCHET STILL FUNCTIONS. THE EVIDENCE SUGGESTS THE RATCHET FEATURE WAS EXERCISED MULTIPLE TIMES TO CAUSE WEAR ON THE RATCHET TAB OF THE BASE SLIDER (USE ERROR).
Description of Event or Problem · 1
IN 2008, THE SALES REP REPORTED THAT DURING SURGERY, THE SURGEON IMPLANTED THE PLATE AND THE LOCKING MECHANISM THAT POPPED OUT. THE SURGEON THEN EXPLANTED THE PLATE AND IMPLANTED ANOTHER ONE. THIS CAUSED A SURGICAL DELAY OF ONE HOUR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANT-CER 1 LVL PLATE ASSY, 24MM | ANTCER | KWQ | ABBOTT SPINE | 52BT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |