MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-01-10 for HALSTEAD FCPS 5 CVD MIRROR 105102 manufactured by Integra York, Pa Inc..
[14885761]
Per customer - tip broke off during surgery. On (b)(6) 2012 per the materials coordinator, during a lumbar spine stimulator surgery, one side of the clamp was discovered to be missing when the surgeon handed back the device to assistant during the surgery. The surgery was delayed for "a few minutes" for an x-ray to be taken, the missing tip was not visualized on x-ray. No further treatment was provided. A visual check of the surgical field and surrounding area was performed; the tip of the device was not found.
Patient Sequence No: 1, Text Type: D, B5
[15298142]
To date, the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2012-00007 |
| MDR Report Key | 2433652 |
| Report Source | 05,06 |
| Date Received | 2012-01-10 |
| Date of Report | 2012-01-10 |
| Date of Event | 2012-01-05 |
| Date Mfgr Received | 2012-01-06 |
| Date Added to Maude | 2012-08-02 |
| 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 | 0 |
| Manufacturer Contact | CAREN FERNANDEZ |
| Manufacturer Street | 315 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HALSTEAD FCPS 5 CVD MIRROR |
| Generic Name | NA |
| Product Code | EJG |
| Date Received | 2012-01-10 |
| Catalog Number | 105102 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-01-10 |