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

Catalog Number 07.02067.001

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 08/13/2019

Event Type  Injury  

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 during a surgical procedure, the tip of the pedicle probe fractured off.The tip was retrieved with additional bone removal and the case was completed using a larger diameter screw and dbm paste.There was surgical delay longer than 30 minutes associated with this event.

Manufacturer Narrative

Additional information: h6 (results, conclusions).The product was not returned and no photos were provided, so an evaluation could not be performed.As such, no evaluation results are available and no conclusions regarding the cause can be drawn.The lot number was not provided, so the manufacturing records could not be reviewed.

Event Description

It was reported that during a surgical procedure, the tip of the pedicle probe fractured off.The tip was retrieved with additional bone removal and the case was completed using a larger diameter screw and dbm paste.There was surgical delay longer than 30 minutes associated with this event.

• Brand Name: PEDICLE PROBE - STRAIGHT LUMBAR
• Type of Device: PROBE
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 9008723
• MDR Text Key: 159608776
• Report Number: 3012447612-2019-00385
• Device Sequence Number: 1
• Product Code: HXB
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.02067.001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/16/2019
• Initial Date FDA Received: 09/12/2019
• Supplement Dates Manufacturer Received: 12/20/2019
• Supplement Dates FDA Received: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other