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

Catalog Number 07.02072.001

Device Problem Material Twisted/Bent (2981)

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

Event Date 01/08/2019

Event Type  malfunction  

Manufacturer Narrative

Udi number: ni.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 the tip of a pedicle probe was found to be bent and twisted.There were no reported patient or surgical impacts associated with this event.

Manufacturer Narrative

Udi number: (b)(4).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 found to be bent and twisted.There were no reported patient or surgical impacts associated with this event.

Manufacturer Narrative

Additional information: method, results, and conclusions - the returned probe was examined.The device tip was twisted.The location where the tip is twisted is consistent with the device having been partially inserted into the bone when a torsional force was applied.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 found to be bent and twisted.There were no reported patient or surgical impacts associated with this event.

• Brand Name: PEDICLE PROBE - CURVED LUMBAR LENKE
• 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: 8298675
• MDR Text Key: 134861963
• Report Number: 3012447612-2019-00048
• 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: 05/01/2019

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: 07.02072.001
• Device Lot Number: 63488016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/10/2019
• Initial Date FDA Received: 02/01/2019
• Supplement Dates Manufacturer Received: 03/22/2019; 04/19/2019
• Supplement Dates FDA Received: 04/08/2019; 05/01/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/18/2017
• 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