MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. SCREW+SS 6.0MMX37.5MM; THE TETHER- VERTEBRAL BODY TETHERING SYSTEM

Model Number N/A

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/08/2020

Event Type  Injury  

Manufacturer Narrative

Device product code: qhp.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.Reference reports 3012447612-2021-00038 to 3012447612-2021-00056.

Event Description

It was reported that there was a delayed presentation of inferior vena cava injury resulting in large volume blood loss in to the right hemithorax following t6-l2 vbt requiring a return to the or on post-op day 2 and multi-unit rbc transfusion.The patient has recovered well.According to the surgeon, this complication is more associated with the surgeon's approach than with implants or instrumentation.This is report sixteen of nineteen for this event.

Event Description

It was reported that there was a delayed presentation of inferior vena cava injury resulting in large volume blood loss in to the right hemithorax following t6-l2 vbt requiring a return to the or on post-op day 2 and multi-unit rbc transfusion.The patient has recovered well.According to the surgeon, this complication is more associated with the surgeon's approach than with implants or instrumentation.This is report sixteen of nineteen for this event.

Manufacturer Narrative

Additional information in d4: expiration date and udi number, h4, and h6: component, investigation type, findings, and conclusions.Device evaluation: product was not returned and photos were not provided, so device evaluation could not be performed.Potential cause root cause was unable to be determined.This event could possibly be attributed to surgical approach as mentioned by the surgeon.Dhr review the dhr was reviewed; there are no indications of manufacturing issues that would have contributed to this event.Device use this device is used for treatment.If additional information is received which changes the information in this report, a follow-up report will be submitted.

• Brand Name: SCREW+SS 6.0MMX37.5MM
• Type of Device: THE TETHER- VERTEBRAL BODY TETHERING SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 11374251
• MDR Text Key: 233568861
• Report Number: 3012447612-2021-00053
• Device Sequence Number: 1
• Product Code: QHP
• Combination Product (y/n): N
• PMA/PMN Number: H190005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 05/19/2021

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 211H6037
• Device Lot Number: 3019621
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 02/24/2021
• Supplement Dates Manufacturer Received: 05/17/2021
• Supplement Dates FDA Received: 05/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention