MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. SCREW+SS 6.0MMX30MM; THE TETHER - VERTEBRAL BODY TETHERING SYSTEM

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reference reports 3012447612-2021-00057 to 3012447612-2021-00069 and 3012447612-2021-00137 to 3012447612-2021-00162.Product code: qhp.The returned device was examined and no indications of damage were observed.The dhr was reviewed and no nonconformances or temporary deviations were associated with this lot that would have impacted the performance of the device; there are no indications of manufacturing-related issues that would have contributed to this event.Based on the information available, the 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 or Problem Description
It was reported that four months post-op, the patient's scoliosis curve changed from 51 degrees pre-op to 19 degrees post-op in the lumbar region, from 68 degrees pre-op to 50 degrees post-op in the thoracic region, but developed a trunk rotation in the thoracic region that measures 30 degrees on the inclinometer reduces to 20 degress in a prone position.The decision was made to remove the construct and fuse the associated levels (t5-l4) together.This is report twenty three of thirty nine for this event.

• Brand Name: SCREW+SS 6.0MMX30MM
• Common Device Name: THE TETHER - VERTEBRAL BODY TETHERING SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 11817405
• Report Number: 3012447612-2021-00146
• Device Sequence Number: 3793013
• Product Code: QHP
• UDI-Device Identifier: 00880304864931
• UDI-Public: (01)00880304864931(17)250131(10)3027404
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: H190005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/12/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 211H6030
• Device Lot Number: 3027404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 05/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 14 YR
• Patient Weight: 39