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 2019-05-31 for PEDICLE PROBE - CURVED LUMBAR LENKE 07.02072.001 manufactured by Zimmer Biomet Spine Inc..
[146679118]
(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
[146679119]
It was reported that the tip of a lenke probe broke off within the patient's pedicle within surgery and could not be retrieved. The probe was being levered on when it broke. An alternative probe was used to complete the remainder of the procedure.
Patient Sequence No: 1, Text Type: D, B5
[169045036]
Additional information: method, results, and conclusions- the returned device was examined. The tip was found to have fractured off likely due to off-axis force. The complaint is confirmed. 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
[169045037]
It was reported that the tip of a lenke probe broke off within the patient's pedicle within surgery and could not be retrieved. The probe was being levered on when it broke. An alternative probe was used to complete the remainder of the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012447612-2019-00244 |
| MDR Report Key | 8659204 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2019-05-31 |
| Date of Report | 2019-11-08 |
| Date of Event | 2019-05-03 |
| Date Mfgr Received | 2019-10-11 |
| Device Manufacturer Date | 2018-08-29 |
| Date Added to Maude | 2019-05-31 |
| 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 | PEDICLE PROBE - CURVED LUMBAR LENKE |
| Generic Name | PROBE |
| Product Code | HXB |
| Date Received | 2019-05-31 |
| Returned To Mfg | 2019-05-16 |
| Model Number | NA |
| Catalog Number | 07.02072.001 |
| Lot Number | 112489 |
| 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 | 2019-05-31 |