MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. SCREW+SS 6.0MMX27.5MM; THE TETHER - VERTEBRAL BODY TETHERING SYSTEM

Catalog Number 211H6027

Device Problem Mechanical Problem (1384)

Patient Problem Deformity/ Disfigurement (2360)

Event Date 08/30/2023

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed to address overcorrection of a tether construct.The set screws were removed from t5-t6 and the cord was removed from t5-t7.An overcorrection was originally measured at 10 degrees during the subject's 1 year visit and was monitored until the next visit.At the next visit approximately 10 weeks later, the misalignment was re-evaluated and changed to reflect the continuing overcorrection, now at 16 degrees near the most proximal end of the construct.This is report four of four for this event.

Manufacturer Narrative

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.

Manufacturer Narrative

Corrections in d1, d4: catalog and lot numbers, d6a, d9, and h3.Additional information in d4: expiration date and udi, and h4.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 3012447612-2023-00319 through 3012447612-2023-00322.

Event Description

It was reported that a revision surgery was performed to address overcorrection of a tether construct.The set screws were removed from t5-t6 and the cord was removed from t5-t7.An overcorrection was originally measured at 10 degrees during the subject's 1 year visit and was monitored until the next visit.At the next visit approximately 10 weeks later, the misalignment was re-evaluated and changed to reflect the continuing overcorrection, now at 16 degrees near the most proximal end of the construct.This is report four of four for this event.

Manufacturer Narrative

H3: "device evaluation anticipated, but not yet begun (02)" no longer applies but cannot be deleted.H6 additional investigation type code: 4109.Corrections in h3.Additional information in h6: component, investigation type, findings, and conclusions.Inspection: an analyses confirmed the presence of frayed fibers and abrasive wear.Frayed fibers could be caused by normal use of the device, occur during removal, interaction with the screw and set screw, or during abnormal loading conditions.Further analysis utilized enzymatic cleaning to remove biological material from the specimen as confirmed by optical microscopy and atr-ftir.Atr-ftir showed that the spectrum of the cleaned cord was qualitatively nearly identical to that of an exemplar component, suggesting that the cord component has not experienced degradation.Dhr review: the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left highridge medical¿s control.Potential 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.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 revision surgery was performed to address overcorrection of a tether construct.The set screws were removed from t5-t6 and the cord was removed from t5-t7.An overcorrection was originally measured at 10 degrees during the subject's 1 year visit and was monitored until the next visit.At the next visit approximately 10 weeks later, the misalignment was re-evaluated and changed to reflect the continuing overcorrection, now at 16 degrees near the most proximal end of the construct.This is report four of four for this event.

• Brand Name: SCREW+SS 6.0MMX27.5MM
• 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.; westminster CO 80021
• Manufacturer Contact: sabrina abla ; 10225 westmoor dr.; westminster, CO 80021 ; 7206965158
• MDR Report Key: 17940013
• MDR Text Key: 325740009
• Report Number: 3012447612-2023-00322
• Device Sequence Number: 1
• Product Code: QHP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H190005
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 211H6027
• Device Lot Number: 3040767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 12 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic