MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-01-22 for KLS 35 MM LENGTH * manufactured by Kls Martin L.p..
[139651]
During surgery on the mandible, the screw broke - entire thread section (approx 15mm). The piece was left in the pt (embedded). Pt suffered no injury.
Patient Sequence No: 1, Text Type: D, B5
[190419]
Add'l info rec'd from mfr 4/3/01: co is not the mfr. Co has forwarded a copy of the med watch to ace surgical supply co who they purchased the product from.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1020964 |
| MDR Report Key | 314440 |
| Date Received | 2001-01-22 |
| Date of Report | 2001-01-22 |
| Date of Event | 2001-01-19 |
| Date Added to Maude | 2001-02-05 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KLS |
| Generic Name | EXTERNAL FIXATOR SCREW |
| Product Code | NDK |
| Date Received | 2001-01-22 |
| Model Number | 35 MM LENGTH |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 304097 |
| Manufacturer | KLS MARTIN L.P. |
| Manufacturer Address | P.O. BOX 50249 JACKSONVILLE FL 322500249 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-01-22 |