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 2019-12-19 for PEDICLE PROBE - STRAIGHT LUMBAR LENKE 07.02077.001 manufactured by Zimmer Biomet Spine Inc..
[173716254]
Without a product return, no product evaluation is able to be conducted. The lot number is unknown; therefore the device history records are unable to be reviewed. 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. Reference report 3012447612-2019-00554.
Patient Sequence No: 1, Text Type: N, H10
[173716255]
It was reported that during the procedure, while the surgeon was pulling the probes out, the tips of two probes broke off. The tips were not able to be retrieved and were retained by the patient. There were no reported surgical delays or additional patient impacts reported. This is report two of two.
Patient Sequence No: 1, Text Type: D, B5
[180667154]
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
[180667155]
It was reported that during the procedure, while the surgeon was pulling the probes out, the tips of two probes broke off. The tips were not able to be retrieved and were retained by the patient. There were no reported surgical delays or additional patient impacts reported. This is report two of two.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012447612-2019-00555 |
| MDR Report Key | 9493687 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2019-12-19 |
| Date of Report | 2020-01-13 |
| Date of Event | 2019-11-19 |
| Date Mfgr Received | 2019-12-18 |
| Date Added to Maude | 2019-12-19 |
| 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 - STRAIGHT LUMBAR LENKE |
| Generic Name | PROBE |
| Product Code | HXB |
| Date Received | 2019-12-19 |
| Returned To Mfg | 2019-12-18 |
| Model Number | NA |
| Catalog Number | 07.02077.001 |
| Lot Number | 63041036 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET SPINE INC. |
| Manufacturer Address | 10225 WESTMOOR DR. WESTMINSTER CO 80021 US 80021 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-12-19 |