FDA Adverse Event
Malfunction
Summary report: N
ARDIS PEEK IMPLANT 14X09X30
MDR report key: 2581241
·
Received May 17, 2012
Report
- Report Number
- 1649384-2012-00047
- Event Type
- Malfunction
- Date Received
- May 17, 2012
- Report Date
- April 25, 2012
- Manufacturer
- ABBOTT SPINE, INC.
- Product Code
- MAX
- PMA / PMN Number
- K073202
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
APPROXIMATELY 1991. PRODUCT IS EXPECTED TO BE RETURNED BUT HAS NOT YET BEEN RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING SURGERY THE IMPLANT BROKE. LEVELS TREATED WERE L3-L4. THE IMPLANT WAS PLACED IN THE DISC SPACE. UPON TAPPING, THE IMPLANT CRACKED AT THE PROXIMAL PORTION. THE BROKEN PIECE WAS REMOVED BUT THE SURGEON WAS UNABLE TO REMOVE THE REMAINING PORTION OF THE IMPLANT AND IT REMAINS IN THE DISC SPACE. THE FINAL INSTRUMENTATION WAS TLIF ONE LEVEL SEQUOIA WITH FUSION. THERE WAS NO DELAY TO THE CASE AND NO IMPACT TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARDIS PEEK IMPLANT 14X09X30 | ARDIS PEEK IMPLANT 14X09X30 | MAX | ABBOTT SPINE, INC. | 3201-140930 | 2130921 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |