MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. SEQUOIA OPEN CLOSURE, 5.5M, TOP TI; SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM

Catalog Number 3301-1

Device Problem Material Deformation (2976)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

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 3012447612-2019-00520 to 3012447612-2019-00529.

Event Description

It was reported that during the procedure the threads of ten closure tops were damaged.The initially-implanted closure tops, that were being removed during this procedure, were used to complete the case.There were no reported patient impacts or surgical delays.This is report nine of ten.

Event Description

It was reported that during the procedure the threads of ten closure tops were damaged.The initially-implanted closure tops, that were being removed during this procedure, were used to complete the case.There were no reported patient impacts or surgical delays.This is report nine of ten.

Manufacturer Narrative

The returned closure top was evaluated.Visual inspection revealed that the threads were damaged.The hexalobes were stripped as well.The complaint is confirmed.A review of the manufacturing records did not identify any issues related to this failure which would have contributed with this event.As this failure is regularly occurring with known causes and impacts, a summary investigation was completed.The likely cause for damaged threads is due to cross-threading.The cross threading can often occur due to misalignment of the screw head on the extender sleeve.The failure of hex damage could have been caused by the closure top cross threading and torque being applied at an angle or over-torquing the construct.

• Brand Name: SEQUOIA OPEN CLOSURE, 5.5M, TOP TI
• Type of Device: SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 9414261
• MDR Text Key: 169206638
• Report Number: 3012447612-2019-00528
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K131980
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3301-1
• Device Lot Number: 78TN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1