FDA Adverse Event
Injury
Summary report: N
SLIMPLICITY ANTERIOR CERVICAL PLATE 4-LEVEL 69
MDR report key: 3258875
·
Received July 30, 2013
Report
- Report Number
- 3005739886-2013-00021
- Event Type
- Injury
- Date Received
- July 30, 2013
- Date of Event
- June 26, 2013
- Report Date
- July 2, 2013
- Manufacturer
- SPINAL USA, INC
- Product Code
- KWQ
- PMA / PMN Number
- K112748
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVAL IN PROCESS. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT UNDERWENT INITIAL IMPLANTATION OF AN ACP 4-LEVEL PLATE ON (B)(6) 2011. RADIOGRAPHS INDICATED SCREW BACK OUT, WORSENING OVER TIME ON SERIAL ROUTINE FOLLOW-UP. THE DOCTOR INDICATED THAT THE PT HAD EVIDENCE OF NON-UNION. REVISION WAS PERFORMED ON (B)(6) 2013, CONFIRMING SCREW BACK OUT AND LOCKING TAB FRACTURE. THE PLATE, SCREWS AND FRACTURED TAB PIECES WERE REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 354220 | SLIMPLICITY ANTERIOR CERVICAL PLATE 4-LEVEL 69 | SPINAL INTERVERTEBRAL BODY FIXATION PLATE | KWQ | SPINAL USA, INC | NA | 2273TI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |