MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2018-11-27 for SHORTENED RIGHT CORONAL BENDER LV00233 manufactured by Zimmer Biomet Spine Inc..
[128567869]
The returned bender was evaluated. A portion of the tip was found to have fractured off in a manner consistent with high force applied to the device during usage. A review of the manufacturing records did not identify any issues which would have contributed to this event.
Patient Sequence No: 1, Text Type: N, H10
[128567870]
It was reported that the tip of a coronal bender worn over time. However, device evaluation by zimmer biomet spine personnel found that a portion of the tip has fractured. There were no reported patient or surgical impacts and the device was able to be used to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012447612-2018-00972 |
| MDR Report Key | 8108581 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-11-27 |
| Date of Report | 2018-11-27 |
| Date of Event | 2018-05-18 |
| Date Mfgr Received | 2018-11-27 |
| Device Manufacturer Date | 2012-07-31 |
| Date Added to Maude | 2018-11-27 |
| 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 | MS. ASHLEY MCPHERSON |
| Manufacturer Street | 10225 WESTMOOR DR. NA |
| Manufacturer City | WESTMINSTER CO 80021 |
| Manufacturer Country | US |
| Manufacturer Postal | 80021 |
| Manufacturer Phone | 3034437500 |
| Manufacturer G1 | ZIMMER BIOMET SPINE INC. |
| Manufacturer Street | 10225 WESTMOOR DR. NA |
| Manufacturer City | WESTMINSTER CO 80021 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80021 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHORTENED RIGHT CORONAL BENDER |
| Generic Name | BENDER |
| Product Code | HXW |
| Date Received | 2018-11-27 |
| Returned To Mfg | 2018-07-19 |
| Model Number | NA |
| Catalog Number | LV00233 |
| Lot Number | 084270 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET SPINE INC. |
| Manufacturer Address | 10225 WESTMOOR DR. NA WESTMINSTER CO 80021 US 80021 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-27 |