MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-02-25 for NOVATION CERAMIC AHS CLUSTER-HOLE SHELL 140-01-54 manufactured by Exactech, Inc..
[18781262]
Revision, reason not reported.
Patient Sequence No: 1, Text Type: D, B5
[18952692]
Pending engineering evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1038671-2015-00048 |
| MDR Report Key | 4576335 |
| Report Source | 07 |
| Date Received | 2015-02-25 |
| Date of Report | 2015-02-25 |
| Date of Event | 2015-01-29 |
| Date Mfgr Received | 2015-01-30 |
| Date Added to Maude | 2015-04-03 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | GRAHAM CUTHBERT |
| Manufacturer Street | 2320 N.W. 66TH CT. |
| Manufacturer City | GAINESVILLE FL 32653 |
| Manufacturer Country | US |
| Manufacturer Postal | 32653 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOVATION CERAMIC AHS CLUSTER-HOLE SHELL |
| Generic Name | SHELL |
| Product Code | KWB |
| Date Received | 2015-02-25 |
| Catalog Number | 140-01-54 |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EXACTECH, INC. |
| Manufacturer Address | 2320 N.W. 66TH CT. GAINESVILLE FL 32653 US 32653 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-02-25 |