FDA Adverse Event
Malfunction
Summary report: N
PAPAVERO-CASPAR SPEC SLIM-PROF 80X11MM
MDR report key: 1082143
·
Received July 25, 2008
Report
- Report Number
- 2916714-2008-00017
- Event Type
- Malfunction
- Date Received
- July 25, 2008
- Date of Event
- June 13, 2008
- Report Date
- July 23, 2008
- Manufacturer
- AESCULAP AG & CO. KG
- Product Code
- EPY
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE IS BEING HELD AT THE USER FACILITY AS PER THEIR POLICY. AESCULAP, INC HAS ATTEMPTED CONTACT WITH THE FACILITY IN ORDER TO FACILITATE RELEASE OF THE DEVICE FOR EVALUATION. ONCE RELEASED, ITEM WILL BE FORWARDED TO THE MANUFACTURING SITE FOR ANALYSIS.
Description of Event or Problem · 1
THE OPENING SCREW STRIPPED WHILE IN THE PATIENT AND HAD TO BE CUT OUT WITH THE DRILL. NO PATIENT INJURY. SURGERY WAS DELAYED FOR TWENTY MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PAPAVERO-CASPAR SPEC SLIM-PROF 80X11MM | EPY | AESCULAP AG & CO. KG | FF589R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |