MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-28 for AMENDIA PADDLE SHAVER 67-03-12 manufactured by Amendia.
[87859425]
An investigation into the report has been initiated. The results of the investigation will be provided in a follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[87859426]
The paddle shaver was used for endplate preparation. While rotating in standard fashion, the shaver was met with resistance. As the surgeon rotated past the resistance, the instrument broke at the connection point of the shaver. The instrument was carefully removed from the disc space and set aside. The surgeon sized down to the 11 mm shaver and proceeded as normal with the case. There was no harm to the patient according to the surgeon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1067095-2017-00019 |
| MDR Report Key | 6900320 |
| Date Received | 2017-09-28 |
| Date of Report | 2017-08-29 |
| Date of Event | 2017-08-29 |
| Date Mfgr Received | 2017-08-29 |
| Date Added to Maude | 2017-09-28 |
| 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. BRUCE HOOPER |
| Manufacturer Street | 1755 W OAK PKWY |
| Manufacturer City | MARIETTA GA 30062 |
| Manufacturer Country | US |
| Manufacturer Postal | 30062 |
| Manufacturer Phone | 6784453784 |
| Manufacturer G1 | AMENDIA |
| Manufacturer Street | 1755 W OAK PKWY |
| Manufacturer City | MARIETTA GA 30062 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30062 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | AMENDIA PADDLE SHAVER |
| Generic Name | PADDLE SHAVER |
| Product Code | HTF |
| Date Received | 2017-09-28 |
| Model Number | 67-03-12 |
| Lot Number | 20160606 |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMENDIA |
| Manufacturer Address | 1755 W OAK PKWY MARIETTA GA 30062 US 30062 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-28 |