FDA Adverse Event
Injury
Summary report: N
VARI-ANGLE HIP SCREW (VHS) SYSTEM
MDR report key: 1192963
·
Received October 13, 2008
Report
- Report Number
- 2242816-2008-00142
- Event Type
- Injury
- Date Received
- October 13, 2008
- Date of Event
- October 3, 2008
- Report Date
- October 8, 2008
- Manufacturer
- EBI, LLC
- Product Code
- KTT
- PMA / PMN Number
- K964880
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITITIONAL PART # 16-235144, 16-235140, 16-235142. THE PACKAGE INSERT INDICATES "NONUNION OR DELAYED UNION THAT MAY LEAD TO BREAKAGE OF THE IMPLANT", AND "BENDING OR FRACTURE OF THE IMPLANT" AS POSSIBLE ADVERSE EFFECTS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SCREWS HAVE BROKE. THE 4 HOLE PLATE WAS THEN REPLACED WITH A 6 HOLE PLATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VARI-ANGLE HIP SCREW (VHS) SYSTEM | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT | KTT | EBI, LLC | 299560 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |