MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. CURVED LUMBAR LENKE VITALITY; PROBE

Catalog Number 07.02072.001

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/13/2024

Event Type  Injury  

Event Description

It was reported when the surgeon used the mallet on the vitality curved lenke probe, the tip fractured based on the stress load.The tip was embedded into the patient's extremely rigid sacral bone.There was a 5-minute day while the surgeon decided what to do.He decided it was safer to leave it in than try to take it out.

Manufacturer Narrative

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.

• Brand Name: CURVED LUMBAR LENKE VITALITY
• Type of Device: PROBE
• Manufacturer (Section D): ZIMMER BIOMET SPINE, INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE, INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer Contact: sabrina abla ; 10225 westmoor dr.; westminster, CO 80021 ; 7206965158
• MDR Report Key: 19003751
• MDR Text Key: 338905357
• Report Number: 3012447612-2024-00063
• Device Sequence Number: 1
• Product Code: HXB
• UDI-Device Identifier: 0088902409943
• UDI-Public: (01)0088902409943(10)102911
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.02072.001
• Device Lot Number: 102911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2024
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic