FDA Adverse Event
Injury
Summary report: N
4.0MM TI QUICK LOCK CANCELLOUS SCREW
MDR report key: 2061257
·
Received April 12, 2011
Report
- Report Number
- 1719045-2011-00182
- Event Type
- Injury
- Date Received
- April 12, 2011
- Report Date
- March 31, 2011
- Manufacturer
- SYNTHES MONUMENT
- Product Code
- KWQ
- PMA / PMN Number
- K971883
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS NOT EXPLANTED. UNABLE TO PROVIDE A DATE OF MANUFACTURE WITHOUT A LOT NUMBER. 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 A DEVICE HISTORY RECORDS REVIEW COULD NOT BE REQUESTED.
Description of Event or Problem · 1
PATIENT STATUS POST PLATE AND SCREW IMPLANTATION RETURNED TO SURGEON FOR POST OP VISIT. AN X-RAY SHOWED ONE QUICK LOCK CANCELLOUS SCREW AT C7 PULLED OUT OF THE CERVICAL SPINE LOCKING PLATE. SURGEON NOTED THE PATIENT WAS HEALED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 4.0MM TI QUICK LOCK CANCELLOUS SCREW | QUICK LOCK CANCELLOUS SCREW | KWQ | SYNTHES MONUMENT | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention | PLATE |