MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-10-12 for MEAD MALLET W/NYLON CAPS 19-796 manufactured by Integra, York - Imiltex.
[2332963]
Customer medwatch # (b)(4) - event description: during acdf (anterior cervical discectomy and fusion), the surgeon was checking the size of spacer needed with trial and handle. The nylon face of the mallet broke over the surgical field. All pieces of the nylon face were retrieved. On (b)(6) 2011, customer reports no pt harm via phone. The original intended procedure: c2-c3, c3-c4 anterior cervical discectomy, osteophytectomy and instrumentation and fusion with titanium grafts. Posterior cervical laminectomy c2-c4 under fluoroscopic guidance. Device usage problem: (eg. Broke, couldn't get it to work or stopped working).
Patient Sequence No: 1, Text Type: D, B5
[9599282]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2011-00074 |
| MDR Report Key | 2404344 |
| Report Source | 06 |
| Date Received | 2011-10-12 |
| Date of Report | 2011-10-12 |
| Date Mfgr Received | 2011-10-05 |
| Date Added to Maude | 2012-07-06 |
| 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 | SANDRA LEE |
| Manufacturer Street | 311 ENTERPRISE DR. |
| Manufacturer City | PLAINSBORO PA 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099366828 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEAD MALLET W/NYLON CAPS |
| Generic Name | M10 - ORTHOPEDIC |
| Product Code | GFJ |
| Date Received | 2011-10-12 |
| Catalog Number | 19-796 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA, YORK - IMILTEX |
| Manufacturer Address | YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-12 |