MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-12 for OPTECURE ALLOGRAFT, 5CC 650-00-05 manufactured by Exactech, Inc.
[31094873]
Pending engineering evaluation.
Patient Sequence No: 1, Text Type: N, H10
[31094874]
Patient contacted exactech via e-mail complaining of pain in her right shoulder after a rtsr on (b)(6) 2008.
Patient Sequence No: 1, Text Type: D, B5
[33454034]
Engineering evaluation noted that the identified unit met all requirements and was acceptable for transplant.
Patient Sequence No: 1, Text Type: N, H10
[33454035]
Patient contacted exactech via e-mail complaining of pain in her right shoulder after a rtsr on (b)(6) 2008.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038671-2015-00659 |
| MDR Report Key | 5220927 |
| Date Received | 2015-11-12 |
| Date of Report | 2015-11-11 |
| Date of Event | 2015-10-02 |
| Date Mfgr Received | 2015-10-07 |
| Date Added to Maude | 2015-11-12 |
| 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 GRAHAM CUTHBERT |
| Manufacturer Street | 2320 NW 66TH CT |
| Manufacturer City | GAINESVILLE FL 32653 |
| Manufacturer Country | US |
| Manufacturer Postal | 32653 |
| Manufacturer Phone | 3523771140 |
| Manufacturer G1 | EXACTECH, INC |
| Manufacturer Street | 2320 NW 66TH CT |
| Manufacturer City | GAINESVILLE FL 32653 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32653 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTECURE ALLOGRAFT, 5CC |
| Generic Name | ALLOGRAFT |
| Product Code | MBP |
| Date Received | 2015-11-12 |
| Catalog Number | 650-00-05 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EXACTECH, INC |
| Manufacturer Address | 2320 NW 66TH CT GAINESVILLE FL 32653 US 32653 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-11-12 |