FDA Adverse Event
Malfunction
Summary report: N
TEMPUS CERVICAL PLATE SYSTEM
MDR report key: 4788983
·
Received May 15, 2015
Report
- Report Number
- 3008853203-2015-00015
- Event Type
- Malfunction
- Date Received
- May 15, 2015
- Date of Event
- March 17, 2015
- Report Date
- May 14, 2015
- Manufacturer
- NEUROSTRUCTURES INC.
- Product Code
- KWQ
- PMA / PMN Number
- K120515
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
USER FACILITY REPORTED THAT A VARIABLE 4MM X 18MM SELF TAPPING SCREW USED TO AFFIX A TEMPUS ANTERIOR CERVICAL PLATE WAS PARTIALLY EXTRUDED DUE TO SLIPPAGE FROM THE BONE. THE TWO ADDITIONAL SCREWS USED TO SECURE THE DEVICE REMAINED IN PLACE AND PROVIDED IMMOBILIZATION. DURING FOLLOW-UP SURGERY ON ENTERPRISE (B)(6) 2015, THE 4.0MM DIAMETER SCREW WAS REPLACED BY A 4.5MM DIAMETER SCREW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 317851 | TEMPUS CERVICAL PLATE SYSTEM | ANTERIOR CERVICAL PLATE SYSTEM | KWQ | NEUROSTRUCTURES INC. | 10-12-014 | 130070 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |