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 2018-08-15 for IN-SITU ROD BENDER ? LEFT 4030 manufactured by Zimmer Biomet Spine Inc..
[117258877]
Udi number: na. The returned rod bender was evaluated. The tip was found to have fractured. The root cause cannot be definitely determined, but it is possible that fracture occurred as additional resistance was placed on the device during usage associated with the patient's large size. A review of the dhr did not identify any issues which would have contributed to this event. The labeling was reviewed and found to contain instructions regarding proper device usage. Reference report 3012447612-2018-00668.
Patient Sequence No: 1, Text Type: N, H10
[117258878]
It was reported that the tips of two rod benders broke off while bend a rod in-situ during surgery. An alternative rod bender was use to complete the procedure without reported patient impacts. This is report one of two for this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012447612-2018-00667 |
| MDR Report Key | 7787399 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-08-15 |
| Date of Report | 2018-08-15 |
| Date of Event | 2017-11-13 |
| Date Mfgr Received | 2017-11-15 |
| Device Manufacturer Date | 2008-10-21 |
| Date Added to Maude | 2018-08-15 |
| 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 | IN-SITU ROD BENDER ? LEFT |
| Generic Name | BENDER |
| Product Code | HXW |
| Date Received | 2018-08-15 |
| Returned To Mfg | 2017-11-30 |
| Model Number | NA |
| Catalog Number | 4030 |
| Lot Number | 028817 |
| 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 | 2018-08-15 |