MAUDE Adverse Event Report: ZIMMER SPINE SEQUOIA TI POLY SCREW ASSY 6.5MM X 45MM

Model Number 3306-6545

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Review of information provided and visual analysis of the returned device concluded that there is no evidence of a product defect.This is the final report that will be submitted associated with this incident and device.No additional action is required at this time.The information contained herein is being provided to the fda to comply with regulations relating to medical device reporting and is based on information submitted by others that may not be factually correct.

Event Description

Same patient as: 2184052-2015-00058, 2184052-2015-00146, and 2184052-2015-00147.Upon investigation of the returned implants, two screws were received with at least one wing sheared off.This was not reported as part of the initial event, and there is no indication from the initial event that this incident caused or contributed to patient injury.The patient was treated for an unknown condition with a nexlink construct from l4 to s1, skipping l5 due to previous pars defect.No unusual events were reported to have occurred during initial implantation.Two days postoperatively the patient stated hearing audible clicking.The patient was seen approximately two weeks later and imaging taken at that time revealed that the right rod had come out of the head of the screw at the s1 level.The patient was revised and the construct was removed.No postoperative patient conditions were provided following device removal.

• Brand Name: SEQUOIA TI POLY SCREW ASSY 6.5MM X 45MM
• Type of Device: SEQUOIA TI POLY SCREW ASSY 6.5MM X 45MM
• Manufacturer (Section D): ZIMMER SPINE; 7375 bush lake road; minneapolis MN 55439
• Manufacturer (Section G): ZIMMER SPINE; 7375 bush lake road; minneapolis MN 55439
• Manufacturer Contact: rikke hanson ; 7375 bush lake road; minneapolis, MN 55439 ; 9528325600
• MDR Report Key: 5324979
• MDR Text Key: 34922278
• Report Number: 2184052-2015-00142
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3306-6545
• Device Catalogue Number: 3306-6545
• Device Lot Number: 62175246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/23/2015
• Initial Date FDA Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2013
• 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: 50 YR