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 Known Impact Or Consequence To Patient (2692)

Event Date 10/16/2018

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

It was reported that a pedicle probe bent during surgery while preparing the screw hole on a patient with very hard bone.The bent device was able to be used to complete the procedure without reported patient impacts.

Manufacturer Narrative

Additional information: the device was not returned for evaluation, so no results are available and no conclusions can be drawn.The lot number is unknown; therefore the device history records are unable to be reviewed.

Event Description

It was reported that a pedicle probe bent during surgery while preparing the screw hole on a patient with very hard bone.The bent device was able to be used to complete the procedure without reported patient impacts.

Manufacturer Narrative

Udi number: (b)(4).Additional information: the returned probe was examined.The device was slightly twisted/bent at the tip.The cause of this event can be attributed to the patient's hard bone as reported by the sales rep.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 bent during surgery while preparing the screw hole on a patient with very hard bone.The bent device was able to be used to complete the procedure without reported patient impacts.

• 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: 8067189
• MDR Text Key: 127214320
• Report Number: 3012447612-2018-00917
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/24/2019

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: 07.02079.001
• Device Lot Number: 102917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/16/2018
• Initial Date FDA Received: 11/13/2018
• Supplement Dates Manufacturer Received: 03/27/2019; 03/29/2019
• Supplement Dates FDA Received: 03/27/2019; 04/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2017
• 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: 44 YR