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 2019-05-14 for PROBE, LUMBAR, CURVED LENKE 730M1004 manufactured by Zimmer Biomet Spine Inc..
[145095016]
(b)(4). Without a product return, no product evaluation is able to be conducted. Current information is insufficient to permit a valid conclusion about the cause of this event. If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Patient Sequence No: 1, Text Type: N, H10
[145095017]
It was reported that a lenke probe bent during surgery while preparing the screw hole. An alternative probe was used to complete the procedure without reported patient impacts.
Patient Sequence No: 1, Text Type: D, B5
[169249181]
Additional information: the returned lumbar curved lenke probe was evaluated. Visual inspection revealed that the tip is bent. Based on the event description and the nature of the failure, the curved lenke possibly experienced higher than normal forces which caused the device to bend during surgery. Additionally, it is unknown what condition of bone that the patient had as hard bone could also have contributed to this event. A review of the manufacturing records 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.
Patient Sequence No: 1, Text Type: N, H10
[169249182]
It was reported that a lenke probe bent during surgery while preparing the screw hole. An alternative probe was used to complete the procedure without reported patient impacts.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012447612-2019-00224 |
| MDR Report Key | 8610084 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2019-05-14 |
| Date of Report | 2019-11-08 |
| Date of Event | 2019-04-18 |
| Date Mfgr Received | 2019-10-09 |
| Device Manufacturer Date | 2018-08-16 |
| Date Added to Maude | 2019-05-14 |
| 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 | PROBE, LUMBAR, CURVED LENKE |
| Generic Name | PROBE |
| Product Code | HXB |
| Date Received | 2019-05-14 |
| Returned To Mfg | 2019-06-19 |
| Model Number | NA |
| Catalog Number | 730M1004 |
| Lot Number | 617612 |
| 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 | 2019-05-14 |