MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-02-07 for ADULT RADIOLUCENT HORSESHOE HEADREST A2010 manufactured by Integra Lifesciences Corporation.
[786334]
The user facility reports that the device came apart during surgery. There was no pt injury reported. Additional info has been requested.
Patient Sequence No: 1, Text Type: D, B5
[7954004]
An investigation has been initiated based upon the reported incident. Correspondence should be sent to: integra lifesciences corp.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004608878-2008-00006 |
| MDR Report Key | 992359 |
| Report Source | 06 |
| Date Received | 2008-02-07 |
| Date of Report | 2008-02-07 |
| Date Mfgr Received | 2008-01-16 |
| Date Added to Maude | 2008-09-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | LATOYA DANDE |
| Manufacturer Street | 311 C ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099366873 |
| Manufacturer G1 | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Street | 4900 CHARLEMAR DR., |
| Manufacturer City | CINCINNATI OH 45227 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 45227 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADULT RADIOLUCENT HORSESHOE HEADREST |
| Generic Name | HEADREST |
| Product Code | HBM |
| Date Received | 2008-02-07 |
| Returned To Mfg | 2008-01-18 |
| Catalog Number | A2010 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 994715 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Address | CINCINNATI OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-02-07 |