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 2019-04-24 for FRENCH ROD BENDER (DIA. 3.5 MM - DIA. 3.8 MM) 07.01770.001 manufactured by Zimmer Biomet Spine Inc..
[142920341]
Current information is insufficient to permit a valid conclusion about the cause of this event. A follow up report will be sent upon completion of the device evaluation.
Patient Sequence No: 1, Text Type: N, H10
[142920342]
It was reported that a french rod bender would not bend a rod appropriately during surgery. In-situ rod benders were used to bend the rod to complete the procedure, but this led to a delay greater than 30 minutes long. There were no reported patient impacts associated with the delay.
Patient Sequence No: 1, Text Type: D, B5
[169035517]
Additional information: (methods, results, an conclusions) - the device was returned and evaluated. Visual inspection revealed no signs of damage. A functional examination showed the rod bender was able to bend a rod without any issues. The complaint is unconfirmed.
Patient Sequence No: 1, Text Type: N, H10
[169035518]
It was reported that a french rod bender would not bend a rod appropriately during surgery. In-situ rod benders were used to bend the rod to complete the procedure, but this led to a delay greater than 30 minutes long. There were no reported patient impacts associated with the delay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012447612-2019-00195 |
| MDR Report Key | 8544892 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2019-04-24 |
| Date of Report | 2019-09-18 |
| Date of Event | 2019-03-25 |
| Date Mfgr Received | 2019-09-06 |
| Device Manufacturer Date | 2014-09-21 |
| Date Added to Maude | 2019-04-24 |
| 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 | FRENCH ROD BENDER (DIA. 3.5 MM - DIA. 3.8 MM) |
| Generic Name | BENDER |
| Product Code | HXW |
| Date Received | 2019-04-24 |
| Returned To Mfg | 2019-04-10 |
| Model Number | NA |
| Catalog Number | 07.01770.001 |
| Lot Number | 62732077 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 1. Other | 2019-04-24 |