FDA Adverse Event
Injury
Summary report: N
SCHANZ SCREW
MDR report key: 2771912
·
Received September 28, 2012
Report
- Report Number
- 2520274-2012-02081
- Event Type
- Injury
- Date Received
- September 28, 2012
- Report Date
- August 31, 2012
- Manufacturer
- SYNTHES USA
- Product Code
- HWC
- PMA / PMN Number
- K082572
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.
Additional Manufacturer Narrative · 1
DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. PLACEHOLDER.
Description of Event or Problem · 1
PATIENT UNDERWENT A PLIF PROCEDURE AT L2-L4 ON AN UNKNOWN DATE. POST-OPERATIVELY THE PATIENT PRESENTED WITH PAIN AND TWO SCHANZ SCREWS WERE NOTED AS BROKEN. THE PATIENT WAS RETURNED TO THE OPERATING ROOM FOR REMOVAL OF THE LEFT L2 AND LEFT L4 SCREWS. THE SURGEON DID NOT REPLACE THE SCREWS AND ADDED INFUSE. NO OTHER HARDWARE WAS CHANGED OR AFFECTED. THIS REPORT IS # 1 OF 2 FOR THE SAME EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCHANZ SCREW | SCHANZ SCREW | HWC | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR | Required Intervention | SCHANZ SCREWS |