FDA Adverse Event
Injury
Summary report: N
3.00MM TI CERVICAL SPINE SCREW
MDR report key: 2120303
·
Received June 2, 2011
Report
- Report Number
- 1719045-2011-00273
- Event Type
- Injury
- Date Received
- June 2, 2011
- Report Date
- May 23, 2011
- Manufacturer
- SYNTHES MONUMENT
- Product Code
- KWP
- PMA / PMN Number
- K073541
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO HAS BEEN REQUESTED. DEVICE NOT EXPLANTED AT THIS TIME, SURGEON IS SCHEDULING. UNABLE TO PROVIDE THE DATE OF MFR AS NO DEVICE WAS RETURNED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE REQUESTED.
Description of Event or Problem · 1
ASYMPTOMATIC PT RETURNED TO SURGEON FOR OFFICE VISIT. AN X-RAY SHOWED ONE SCREW BACKING OUT OF THE ZERO-P IMPLANT, LEVEL UNK. SURGEON NOTED THE IMPLANT WAS IN GOOD POSITION. SURGEON IS SCHEDULING A REVISION TO REMOVE PRODUCT. THIS IS ONE OF TWO REPORTS FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3.00MM TI CERVICAL SPINE SCREW | TI CERVICAL SPINE SCREW | KWP | SYNTHES MONUMENT | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention | PLATE |