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 Known Impact Or Consequence To Patient (2692)

Event Date 07/13/2020

Event Type  malfunction  

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.Reference reports 3012447612-2020-00434 to 3012447612-2020-00444.

Event Description

It was reported a screw was removed and replaced after ten set screws were stripped in the pedicle screw tulip head.An alternate screw and set screw were used to complete the case with no reported patient harm.This is report two of eleven for this event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D4: udi#: (b)(4).D6: not implanted.D7: not explanted.D11: catalog#: 3505-6540, 6.5x40mm path nxt cann pa scr, lot#: 88mw, qty: 1.Catalog#: 3301-1, sequoia closure top, lot#: aas, qty: 2.Catalog#: 3301-1 ,sequoia closure top, lot#: aax , qty: 7.The following sections were updated/corrected.Updated: b4, b5, d10, d11, g4, g7, h2, h3, h4, h6, h10.Corrected: d6, d7.The device was returned to the manufacturer, however the reported event could not be confirmed.Upon inspection, there were no bends in the threads and the device functioned as intended.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• 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: 10386050
• MDR Text Key: 203155750
• Report Number: 3012447612-2020-00435
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• 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: AAS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Age: 34 YR