FDA Adverse Event
Other
Summary report: N
POLYAXIAL SCREWDRIVER LOCKING
MDR report key: 2854064
·
Received September 14, 2012
Report
- Report Number
- 3005739886-2012-00009
- Event Type
- Other
- Date Received
- September 14, 2012
- Date of Event
- August 22, 2012
- Report Date
- August 22, 2012
- Manufacturer
- TECH INDUSTRIES
- Product Code
- HXX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DR
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
RESULTS, CONCLUSIONS: EVALUATION IN PROCESS, UPON COMPLETION A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A PROCEDURE, WHEN REMOVING DRIVER FROM THE SCREW, THE TIP FRACTURED. THE FRACTURED TIP WAS RETAINED IN THE HEAD OF THE SCREW WHICH REMAINS IMPLANTED IN THE PATIENT. THE RETAINED TIP DID NOT INTERFERE WITH THE PLACING OF THE ROD OR THE LOCKING CAP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POLYAXIAL SCREWDRIVER LOCKING | POLYAXIAL SCREWDRIVR LOCKING | HXX | TECH INDUSTRIES | 2315TI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |