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 |