MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-25 for RESURFACING CAGE TAMP 313-05-10 manufactured by Exactech, Inc.
[66019881]
The contribution of the devices to the experience reported could not be determined as the instrument was not returned for evaluation. Additionally, the device specific information was not provided, precluding a review of the device history record.
Patient Sequence No: 1, Text Type: N, H10
[66019882]
During the tamping stage for the cage (25 mm) of a resurfacing hemi, a small fracture running across the head of the humerus was caused.
Patient Sequence No: 1, Text Type: D, B5
[110091197]
The contribution of the devices to the experience reported could not be determined as the instrument was not returned for evaluation. Additionally, the device specific information was not provided, precluding a review of the device history record.
Patient Sequence No: 1, Text Type: N, H10
[110091198]
During the tamping stage for the cage (25mm) of a resurfacing hemi, a small fracture running across the head of the humerus was caused.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038671-2017-00034 |
| MDR Report Key | 6277461 |
| Date Received | 2017-01-25 |
| Date of Report | 2017-07-26 |
| Date of Event | 2017-01-04 |
| Report Date | 2016-10-27 |
| Date Reported to Mfgr | 2016-10-27 |
| Date Mfgr Received | 2016-10-27 |
| Date Added to Maude | 2017-01-25 |
| 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 | 0 |
| Brand Name | RESURFACING CAGE TAMP |
| Generic Name | RESURFACING CAGE TAMP |
| Product Code | HXG |
| Date Received | 2017-01-25 |
| Catalog Number | 313-05-10 |
| 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 | 2017-01-25 |