FDA Adverse Event
Malfunction
Summary report: N
NI
MDR report key: 1915284
·
Received November 17, 2010
Report
- Report Number
- 2520274-2010-00212
- Event Type
- Malfunction
- Date Received
- November 17, 2010
- Report Date
- October 27, 2010
- Manufacturer
- SYNTHES (USA)
- Product Code
- HWC
- PMA / PMN Number
- NI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS INFO WAS NOT PROVIDED DURING THE INITIAL REPORT. ADD'L INFO HAS BEEN REQUESTED. SUBJECT DEVICE HAS NOT BEEN EXPLANTED. SYNTHES IS UNABLE TO PROVIDE THE MFR, PMA/510K NUMBER AND/OR THE DATE OF MANUFACTURE AS NO PRODUCT WAS RETURNED AND NO PART/LOT NUMBER WAS PROVIDED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED AND NO PART/LOT NUMBER WAS PROVIDED.
Description of Event or Problem · 1
PT STATUS POST IMPLANTATION WITH TWO PLATES AND SCREWS HAS CELLULITIS AND AN UNSTABLE CHEST. SURGEON IS MONITORING THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NI | NI | HWC | SYNTHES (USA) | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |