MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-17 for TURNKEY FCS FCS-400 manufactured by Hand Biomechanics Lab, Inc..
[105755540]
Reviewed sterilization and sterile barrier inspection records for lot. No pattern related to irradiation dose lot or device lot was noted. Confirmed labeling included cautions regarding pin site care.
Patient Sequence No: 1, Text Type: N, H10
[105755541]
Patient had surgery to install a turnkey fcs external fixation device. Physician reported device was removed 3 weeks post operative because of a pin site infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2919128-2018-00008 |
| MDR Report Key | 7437849 |
| Date Received | 2018-04-17 |
| Date of Report | 2018-12-27 |
| Date Mfgr Received | 2008-12-04 |
| Device Manufacturer Date | 2008-11-06 |
| Date Added to Maude | 2018-04-17 |
| 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 | 3 |
| Manufacturer Contact | MR. DUSTIN DEQUINE |
| Manufacturer Street | 77 SCRIPPS DRIVE, SUITE 104 |
| Manufacturer City | SACRAMENTO CA 95825 |
| Manufacturer Country | US |
| Manufacturer Postal | 95825 |
| Manufacturer Phone | 9169235073 |
| Manufacturer G1 | HAND BIOMECHANICS LAB, INC. |
| Manufacturer Street | 77 SCRIPPS DRIVE, SUITE 104 |
| Manufacturer City | SACRAMENTO CA 95825 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95825 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TURNKEY FCS |
| Generic Name | TURNKEY FCS |
| Product Code | JEC |
| Date Received | 2018-04-17 |
| Model Number | FCS-400 |
| Catalog Number | FCS-400 |
| Lot Number | FXD-108-199 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HAND BIOMECHANICS LAB, INC. |
| Manufacturer Address | 77 SCRIPPS DRIVE, SUITE 104 SACRAMENTO CA 95825 US 95825 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2018-04-17 |