MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. TETHER SET SCREW, UNKNOWN SIZE; THE TETHER - VERTEBRAL BODY TETHERING SYSTEM

Catalog Number 211HXXXX

Device Problem Malposition of Device (2616)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/10/2023

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 a set screw was found to be cross-threaded (not sitting concentrically) in its screw at t7 during review of x-rays taken prior to the patient being discharged from the hospital.A revision surgery was performed the next day to remove and replace the set screw.During the revision surgery, the set screw was found to be secure (not loosened) within its screw and the cord was tight.The surgeon did not see any damage to the set screw after it was removed.

Manufacturer Narrative

Additional method code: 4109.Corrected information in b6 and g1: email address.Additional information in h6: component, investigation type, findings, and conclusions.Inspection: the product was not returned, so an evaluation is unable to be performed.However, a video was provided which shows that the installed set screw is not sitting flush/concentrically in the bone screw.X-rays were also provided; the pre-revision x-ray confirms the set screw was sitting proud in its bone screw compared to the screws on either side of it.The video and x-ray confirm the set screw was not installed correctly, but do not allow for detection of any damage, deformation, or any other issue that may have contributed to the event.Dhr review: the lot number was not provided, so the dhr was unable to be reviewed.Potential root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to off-axis forces applied during use or misalignment of the set screw during insertion.Device usage: this device is used for treatment.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.

Event Description

It was reported that a set screw was found to be cross-threaded (not sitting concentrically) in its screw at t7 during review of xrays taken prior to the patient being discharged from the hospital.A revision surgery was performed the next day to remove and replace the set screw.During the revision surgery, the set screw was found to be secure (not loosened) within its screw and the cord was tight.The surgeon did not see any damage to the set screw after it was removed.

• Brand Name: TETHER SET SCREW, UNKNOWN SIZE
• Type of Device: THE TETHER - VERTEBRAL BODY TETHERING 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: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 16485109
• MDR Text Key: 310688796
• Report Number: 3012447612-2023-00061
• Device Sequence Number: 1
• Product Code: QHP
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: H190005
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 211HXXXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic