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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/12/2021

Event Type  Injury  

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 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 eight of thirty nine for this event.

• Brand Name: SCREW+SS 6.0MMX32.5MM
• 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: 11817426
• MDR Text Key: 250385247
• Report Number: 3012447612-2021-00151
• Device Sequence Number: 1
• Product Code: QHP
• UDI-Device Identifier: 00880304864948
• UDI-Public: (01)00880304864948(17)241231(10)3019440
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H190005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 211H6032
• Device Lot Number: 3019440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 14 YR
• Patient Weight: 39