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

Catalog Number 07.02078.001

Device Problem Material Twisted/Bent (2981)

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

Event Date 08/13/2018

Event Type  malfunction  

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 the tip of a pedicle probe was bent during surgery.There were no surgical impacts reported in association with this event.

Manufacturer Narrative

Udi number: (b)(4).Additional information: the returned probe was examined and found to have a bent tip.The cause of this event is unknown but it is possible the probe could have been bent due to excess force, hard patient bone during surgery, off-axis use, or mishandling during cleaning.A review of the dhr did not find any issues which would have contributed to this event.

Event Description

It was reported that the tip of a pedicle probe was bent during surgery.There were no surgical impacts reported in association with this event.

• Brand Name: PEDICLE PROBE - THORACIC CURVED
• 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: 8066947
• MDR Text Key: 127076840
• Report Number: 3012447612-2018-00903
• 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: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.02078.001
• Device Lot Number: 63041037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/15/2018
• Initial Date FDA Received: 11/13/2018
• Supplement Dates Manufacturer Received: 03/29/2019
• Supplement Dates FDA Received: 04/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2016
• 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
• Patient Age: 16 YR