MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CLOSURE TOP TORQUE LIMITING; VITALITY SPINAL FIXATION SYSTEM

Catalog Number 07.02010.001

Device Problem Migration (4003)

Patient Problem No Information (3190)

Event Date 07/08/2019

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 a closure top migrated post-operatively.No further information has been provided.

Manufacturer Narrative

Additional information: the implant 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 closure top migrated post-operatively.No further information has been provided.

• Brand Name: CLOSURE TOP TORQUE LIMITING
• Type of Device: VITALITY SPINAL FIXATION SYSTEM
• 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: 8861421
• MDR Text Key: 153383678
• Report Number: 3012447612-2019-00325
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150896
• 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: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.02010.001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1