FDA Adverse Event
Injury
Summary report: N
APPLICATION INSTR W/ALIGNMENT
MDR report key: 1131931
·
Received August 22, 2008
Report
- Report Number
- 2520274-2008-00059
- Event Type
- Injury
- Date Received
- August 22, 2008
- Date of Event
- July 9, 2008
- Report Date
- July 31, 2008
- Manufacturer
- SYNTHES (USA)
- Product Code
- LXH
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS INFO WAS NOT PROVIDED DURING THE INITIAL REPORT. ADD'L INFO HAS BEEN REQUESTED. SYNTHES IS UNABLE TO DETERMINE THE MFG DATE OR THE MFR SITE WITHOUT A LOT NUMBER. NO INVESTIGATION COULD BE PERFORMED, NO CONCLUSION DRAWN, AS NO DEVICE WAS RETURNED.
Description of Event or Problem · 1
PT COMPLAINED OF DISCOMFORT STATUS POST CRANIOTOMY. A CT SCAN SHOWED THAT THE FLAP WAS FREE AND MIGRATING. THE SURGEON REPORTED THAT DURING THE REVISION IT WAS REVEALED THE TUBE CLAMPS FAILED. SURGEON NOTED THAT THE ALIGNMENT TOOL HAD BEEN DIFFICULT TO USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | APPLICATION INSTR W/ALIGNMENT | APPLICATION INSTRUMENT W/ALIGNMENT TOOL | LXH | SYNTHES (USA) | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention | TI CRANIAL FLAP TUBE CLAMPS |