MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 5.5 PRECUT CURVED RODS, TI ALLOY 110MM; VITALITY SPINAL FIXATION SYSTEM

Catalog Number 07.02015.019

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 08/29/2019

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.3012447612-2019-00459 and 3012447612-2019-00460.

Event Description

It was reported that a patient underwent a revision surgery to remove a pedicle screw, closure top, and rod.There was no further surgical or patient information was provided.This is report three of three.

Manufacturer Narrative

Additional information in b4, g4, g7, h2, h6: results, and conclusion codes.The device was not returned for evaluation; however, a picture was provided.Photos provided do not show evidence of a device malfunction.The complaint is unrefuted for a revision surgery.Without product return a full evaluation cannot be completed so no evaluation results are available.The lot number for this specific device was not provided.Therefore, the device history record (dhr) review cannot be performed in this case.It was reported that a patient underwent a revision surgery to remove a pedicle screw, closure top, and rod.The reported complaint could not be verified.The exact cause of this event can't be determine with the available information.

Event Description

It was reported that a patient underwent a revision surgery to remove a pedicle screw, closure top, and rod.There was no further surgical or patient information was provided.This is report (b)(4) of (b)(4).

• Brand Name: 5.5 PRECUT CURVED RODS, TI ALLOY 110MM
• Type of Device: VITALITY SPINAL FIXATION SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 9380567
• MDR Text Key: 168189560
• Report Number: 3012447612-2019-00462
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K150896
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 07.02015.019
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR