MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CORD 300MM; VERTEBRAL BODY TETHERING SYSTEM

Catalog Number 204H0300

Device Problem Mechanical Problem (1384)

Patient Problem No Code Available (3191)

Event Date 09/22/2020

Event Type  Injury  

Manufacturer Narrative

Device product code: qhp.Without a product return, no product evaluation is able to be conducted.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 patient underwent a tether revision surgery after it was discovered the lumbar curve was increasing postoperatively and the surgeon felt tension needed to released from the cord.The cord was removed and replaced with an alternate to complete the case.There were no additional patient impacts reported.

Manufacturer Narrative

Correction in h9.Additional information in d4: idu, h4, and h6: method, results, and conclusions.This follow-up report is being submitted to relay additional information and initially corrected information.Inspection: the product was not returned and no photos were provided, so an evaluation is unable to be performed.As such, no evaluation results are available.Dhr review: the dhr was reviewed.There were no nonconformities or temporary deviations associated with this failure on this lot.All characteristics inspected upon initial receipt were found conforming to specifications.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left zimmer biomet¿s control.Complaint history: a complaint history review was performed.Potential root cause as the product was not returned and an analysis could not be performed, a cause cannot be determined.A follow-up report will be submitted if new information is received that changes the information provided in this report.

Event Description

It was reported that a patient underwent a tether revision surgery after it was discovered the lumbar curve was increasing postoperatively and the surgeon felt tension needed to be released from the cord.The cord was removed and replaced with and alternate to complete the case.There were no additional patient impacts reported.

• Brand Name: CORD 300MM
• Type of Device: VERTEBRAL BODY TETHERING SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 10718688
• MDR Text Key: 212512076
• Report Number: 3012447612-2020-00589
• Device Sequence Number: 1
• Product Code: QHP
• Combination Product (y/n): N
• PMA/PMN Number: H190005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 204H0300
• Device Lot Number: 2966466
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention