MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-08-11 for WRIST FUSION SYSTEM 07-5000 manufactured by Kinetikos Medical, Inc..
[20194362]
On 27 july, 2006, kinetikos medical, inc. , was informed of the explant of a wrist fusion system implant from a male pt to address pain. The original implant date was not reported, nor was the original implanting surgeon identified. The explanted components were not returned to kmi for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[20452115]
Kinetikos medical, inc sub-rep was present at the explant surgery in 2006. The pt had registered wrist pain. The pt's bone quality (density) was reported as 'normal'. The desired four-corner fusion of the carpal bones had not occurred. One bone screw appeared too long for the particular location it was positioned in (having protruded through and in to an unspecified carpal bone joint). Another bone screw had broken at the head close to the plate. The pt was not asked about a traumatic event that could have precipitated the breakage. No components were returned to kmi for eval as the pt insisted on keeping them for himself. The subject bone screw lot file could therefore not be researched. The explanting physician does not use the spider wrist fusion system for four-corner fusion procedures owing to what he refers to as limited x-ray interpretation of fusion. He did not venture an opinion as to the efficacy or quality of the original implant surgery technique experienced by this pt. It was not revealed why the original implanting surgeon did not participate in this explant. Corrective/preventive action planned: the root cause of the pt's pain appears to be a combination of inappropriate bone screw length selection (which resulted in carpal joint impingement) and/or a broken bone screw, the cause of which was not established. Given the (very) limited info made available, no corrective or preventive actions can be recommended.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028840-2006-00015 |
| MDR Report Key | 748812 |
| Report Source | 07 |
| Date Received | 2006-08-11 |
| Date of Report | 2006-08-08 |
| Date of Event | 2006-07-19 |
| Date Added to Maude | 2006-08-16 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Street | 6005 HIDDEN VALLEY RD SUITE 180 |
| Manufacturer City | CALSBAD CA 92011 |
| Manufacturer Country | US |
| Manufacturer Postal | 92011 |
| Manufacturer Phone | 7604481706 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WRIST FUSION SYSTEM |
| Generic Name | ORTHOPEDIC WRIST IMPLANT |
| Product Code | KWM |
| Date Received | 2006-08-11 |
| Model Number | 07-5000 |
| Catalog Number | 07-5000 |
| Lot Number | NI |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 736595 |
| Manufacturer | KINETIKOS MEDICAL, INC. |
| Manufacturer Address | * CARLSBAD CA 92011 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-08-11 |