FDA Adverse Event
Malfunction
Summary report: N
MAYFIELD TRIAD SKULL CLAMP
MDR report key: 2151408
·
Received June 21, 2011
Report
- Report Number
- 3004608878-2011-00081
- Event Type
- Malfunction
- Date Received
- June 21, 2011
- Report Date
- June 21, 2011
- Manufacturer
- INTEGRA, CINCINNATI
- Product Code
- HBL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.
Description of Event or Problem · 1
A NEW TRIAD SKULL CLAMPS' SWIVEL ADAPTOR WOULD NOT LOCK. THE STAFF ATTEMPTED TO APPLY THE UNIT TO THE PT WHEN THE PROBLEM WAS FOUND. IT IS UNK WHETHER THE PT INCURRED AN INJURY AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAYFIELD TRIAD SKULL CLAMP | SKULL CLAMPS AND HEADREST SYSTEMS | HBL | INTEGRA, CINCINNATI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |