MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. SCREW+SS 6.0MMX32.5MM; THE TETHER - VERTEBRAL BODY TETHERING SYSTEM

Catalog Number	211H6032
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	07/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4: the remainder of the udi number is unknown because the lot number is not available.Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.Reference reports 3012447612-2024-00261 and 3012447612-2024-00309.
Event or Problem Description
It was reported that a revision surgery was performed to release a tether cord between t11 and l2 because the patient has 16 degrees of overcorrection.The overcorrection was discovered during a 3 year post-operative follow-up visit.During the revision, the cord was found broken between t11 and t12.The cord between t11 and l2 and the screws between t11 and l1 were removed during the procedure.This is report four of four for this event.
Additional Manufacturer Narrative
H3: "device evaluation anticipated, but not yet begun" is erroneous and no longer applies.The device was evaluated.H6: additional method code: 4110.Corrections in h3.Additional information in h6: investigation type, findings, and conclusions.Device evaluation: no x-ray images were provided, therefore curve overcorrection could not be confirmed.The device was sent to exponent for evaluation.Exponent's analysis found signs of use but no damage.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to unknown patient or surgical factors.Dhr review: the lot number was not reported, therefore a dhr review is unable to be performed.Device usage: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
Event or Problem Description
It was reported that a revision surgery was performed to release a tether cord between t11 and l2 because the patient has 16 degrees of overcorrection.The overcorrection was discovered during a 3 year post-operative follow-up visit.During the revision, the cord was found broken between t11 and t12.The cord between t11 and l2 and the screws between t11 and l1 were removed during the procedure.This is report four of four for this event.

• Brand Name: SCREW+SS 6.0MMX32.5MM
• Common Device Name: 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.; westminster CO 80021
• Manufacturer Contact: teresa george ; 10225 westmoor dr.; westminster, CO 80021 ; 3035018506
• MDR Report Key: 20634375
• Report Number: 3012447612-2024-00311
• Device Sequence Number: 7463725
• Product Code: QHP
• UDI-Device Identifier: 00880304864948
• UDI-Public: (01)00880304864948
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: H190005
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2025

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 211H6032
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 14 YR
• Patient Sex: Female
• Patient Weight: 47 KG
• Patient Ethnicity: Non Hispanic