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

Catalog Number 07.02079.001

Device Problem Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Date 06/24/2018

Event Type  malfunction  

Manufacturer Narrative

(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.

Event Description

It was reported that a pedicle probe was found to have a bent tip during a routine inspection.There were no surgical or patient impacts associated with this event.

Manufacturer Narrative

Additional information: the lenke was not returned and no photos were provided, so an evaluation is unable to be performed.As such, the cause of failure cannot be determined at this time since the conditions of use when the device failed are also unknown.A review of the manufacturing records did not show any discrepancies that would have contributed to the failure reported.

Manufacturer Narrative

The returned probe was examined and found to be bent at the tip.The reason for this event cannot be determined with the information provided, however, dense bone quality of the patient, off-axis use of the probe, or attempting to alter the trajectory of the probe within the vertebrae in a previous case are all possible causes.A review of the dhr did not find any issues which would have contributed to this event.

Event Description

It was reported that a pedicle probe was found to have a bent tip during a routine inspection.There were no surgical or patient impacts associated with this event.

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.

Event Description

It was reported that a pedicle probe was found to have a bent tip during a routine inspection.There were no surgical or patient impacts associated with this event.

• Brand Name: PEDICLE PROBE - CURVED LUMBAR
• 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: 7763609
• MDR Text Key: 116536993
• Report Number: 3012447612-2018-00611
• Device Sequence Number: 1
• Product Code: HXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 07.02079.001
• Device Lot Number: 63041038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2015
• 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