MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-01-10 for RESURFACING CAGE TAMP 313-05-10 manufactured by Exactech, Inc.
[64361614]
The contribution of the devices to the experience reported could not be determined as the devices were 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
[64361615]
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
[109149446]
The contribution of the devices to the experience reported could not be determined as the instrument was not returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[109149447]
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
[109151071]
The contribution of the devices to the experience reported could not be determined as the instrument was not returned for evaluation. Engineering evaluation noted that the the intra-operative bone fracture reported was likely the result of the reaming/tamping technique. The design team was consulted and concluded that if the surgeon would have reamed deeper to get through the hard cortical bone, they likely would not have seen the crack. "unintended bone fractures" is listed in the product labeling for the resurfacing system under device specific risks.
Patient Sequence No: 1, Text Type: N, H10
[109151074]
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 | 1038671-2017-00003 |
| MDR Report Key | 6237563 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-01-10 |
| Date of Report | 2018-05-22 |
| Date of Event | 2016-10-26 |
| Date Mfgr Received | 2016-10-27 |
| Date Added to Maude | 2017-01-10 |
| 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 | RESURFACING CAGE TAMP |
| Generic Name | RESURFACING CAGE TAMP |
| Product Code | HXG |
| Date Received | 2017-01-10 |
| 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 | 2017-01-10 |