FDA Adverse Event
Injury
Summary report: N
MAYFIELD ULTRA BASE UNIT
MDR report key: 4092375
·
Received September 4, 2014
Report
- Report Number
- 3004608878-2014-00159
- Event Type
- Injury
- Date Received
- September 4, 2014
- Report Date
- August 15, 2014
- Manufacturer
- INTEGRA LIFESCIENCES CORPORATION OH/USA
- Product Code
- HBL
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE, THE DEVICES INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED UPON THE REPORTED INFORMATION.
Description of Event or Problem · 1
ON AN UNKNOWN DATE, THE PATIENT WAS UNDERGOING A 360 SURGERY TO THE C SPINE. WHEN THEY FLIPPED THE PATIENT OT FACE DOWN POSITION, THE SKULL CLAMP WAS DISCONNECTED FROM THE SWIVEL ADAPTOR FOR THE FLIP. WHEN SECURING TO THE ADAPTOR AFTER FLIPPING THE PATIENT, EXCESSIVE BLOOD WAS NOTICED AND THE PHYSICIAN NOTICED THE CLAMP HAD SLIPPED, CUTTING THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 541501 | MAYFIELD ULTRA BASE UNIT | NONE | HBL | INTEGRA LIFESCIENCES CORPORATION OH/USA | 081 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | MAYFIELD SWIVEL ADAPTOR (A1018)| MAYFIELD MODIFIED SKULL CLAMP (A1059) |