FDA Adverse Event
Injury
Summary report: N
4.0MM TI CORTEX EXPANSIONHEAD SCREW SELF-TAPPING 14MM
MDR report key: 2023859
·
Received March 14, 2011
Report
- Report Number
- 8030965-2011-00070
- Event Type
- Injury
- Date Received
- March 14, 2011
- Date of Event
- January 25, 2011
- Report Date
- February 17, 2011
- Manufacturer
- SYNTHES MONUMENT
- Product Code
- KWQ
- PMA / PMN Number
- K031276
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS INFORMATION WAS NOT PROVIDED DURING INITIAL REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. INVESTIGATION IS ON GOING; NO CONCLUSION CAN BE DRAWN AS NO DEVICE WAS RETURNED. REVIEW OF THE MANUFACTURING RECORDS HAS BEEN REQUESTED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING DATE WITHOUT A LOT NUMBER.
Description of Event or Problem · 1
PATIENT IMPLANTED WITH CERVICAL SPINE LOCKING PLATE AND SCREWS AT C5-C7 ON (B)(6) 2011. ONE WEEK POSTOP, IT WAS NOTED THAT THE PLATE AND SCREW CONSTRUCT ANGLE HAD CHANGED. PATIENT WAS REVISED (B)(6) 2011 TO ANOTHER PLATE. THIS IS THE SECOND OF 5 REPORTS SUBMITTED ON THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 4.0MM TI CORTEX EXPANSIONHEAD SCREW SELF-TAPPING 14MM | EXPANSIONHEAD SCREWS | KWQ | SYNTHES MONUMENT | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention | PLATE| SCREWS |