MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CURVED LUMBAR PEDICLE PROBE

Catalog Number 14-500003

Device Problem Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/29/2018

Event Type  malfunction  

Manufacturer Narrative

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.Reference report 3012447612-2019-00005.

Event Description

It was reported that the tips of two probes bent while preparing the screw holes during surgery.An alternative probe was used to complete the procedure without reported impacts.This is report two of two for this event.

Manufacturer Narrative

Information was entered in error; there are no changes from the initial submission.Additional information: method, results, and conclusions - the device was not returned for evaluation.However, pictures were provided confirming the bent instrument.The patient was reported to have hard bone, which likely caused the bending.

Event Description

It was reported that the tips of two probes bent while preparing the screw holes during surgery.An alternative probe was used to complete the procedure without reported impacts.This is report two of two for this event.

• Brand Name: CURVED LUMBAR PEDICLE PROBE
• 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.; na; westminster CO 80021
• Manufacturer Contact: ashley mcpherson ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 8215596
• MDR Text Key: 132081186
• Report Number: 3012447612-2019-00006
• Device Sequence Number: 1
• Product Code: HXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14-500003
• Device Lot Number: 562098
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1