MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-02-22 for IN SITU ROD BENDER, LEFT (DIA. 3.8MM) 07.01771.002 manufactured by Zimmer Biomet Spine Inc..
[136854625]
(b)(4). 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
[136854626]
It was reported that the tip of an in-situ rod bender was found broken off after the device went through sterile processing at the end of a procedure. It is unknown when the tip of the device broke off. There were no reports of patient or surgical impacts associated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012447612-2019-00085 |
| MDR Report Key | 8361429 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-02-22 |
| Date of Report | 2019-06-28 |
| Date of Event | 2019-01-18 |
| Date Mfgr Received | 2019-06-17 |
| Device Manufacturer Date | 2015-01-08 |
| Date Added to Maude | 2019-02-22 |
| 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 (DIA. 3.8MM) |
| Generic Name | BENDER |
| Product Code | HXW |
| Date Received | 2019-02-22 |
| Returned To Mfg | 2019-02-18 |
| Model Number | NA |
| Catalog Number | 07.01771.002 |
| Lot Number | 62874477 |
| 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 | 2019-02-22 |