MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2002-05-10 for FREEHAND SYSTEM FHS 1000 * manufactured by Neurocontrol Corp..
[18193670]
This patient was implanted (right hand) with the freehand system hand grasp neuroprosthesis in 2002. Common to the freehand system implantation procedure is the insertion of an orthopedic fixation pin (unknown mfr. , model, etc. ) to facilitate bone fusion, and such a pin was inserted in this patient's right thumb. However, this fixation pin was reportedly cut shorter than normal and was subsequently covered by skin overgrowth and not removed at the standard removal point. The patient developed an infection, the pin was then discovered and removed (removal date is unknown), and the patient was treated with antibiotics. The current status of this patient is unknown and a follow up report will be provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530440-2002-00006 |
| MDR Report Key | 393424 |
| Report Source | 04 |
| Date Received | 2002-05-10 |
| Date of Report | 2002-04-10 |
| Date Mfgr Received | 2002-04-10 |
| Date Added to Maude | 2002-05-14 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL SOUTHWORTH |
| Manufacturer Street | 8333 ROCKSIDE ROAD |
| Manufacturer City | VALLEY VIEW OH 44125 |
| Manufacturer Country | US |
| Manufacturer Postal | 44125 |
| Manufacturer Phone | 2169120101 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FREEHAND SYSTEM |
| Generic Name | HAND GRASP NEUROPROSTHESIS |
| Product Code | GZC |
| Date Received | 2002-05-10 |
| Model Number | FHS 1000 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 382446 |
| Manufacturer | NEUROCONTROL CORP. |
| Manufacturer Address | 8333 ROCKSIDE ROAD VALLEY VIEW OH 44125 US |
| Baseline Brand Name | FREEHAND SYSTEM |
| Baseline Generic Name | HAND GRASP NEUROPROSTHESIS |
| Baseline Model No | FHS 1000 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | NEUROCONTROL FREEHAND SYSTEM |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | Y |
| Premarket Approval | P9500 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-05-10 |