MAUDE Adverse Event Report: ZIMMER SPINE SEQUOIA TI POLY SCREW ASSY 5.5MM X 40MM

Model Number 3306-5540

Device Problems Detachment Of Device Component (1104); Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

The condition of the returned device was consistent with the reported event.Review of the information provided and analysis of the returned device concluded that there is no evidence of a product defect.The root cause is most likely related to post-operative non/compliance or trauma.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 case as: 2184052-2015-00103.It was reported that post-operative screw disassociation occurred.The patient underwent an anterior lumbar interbody fusion with a non-zimmer device along with sequoia hardware placed posteriorly from l5 to s1 to treat grade 2-3 l5-s1 spondylolisthesis.X-rays later revealed post-operative fracture of the l5 left pedicle and disassociation of the tulip head from the screw on the l5 right pedicle.Based on this and the appearance/condition of the non-zimmer alif cage on the films, the surgeon suspects that the patient may have engaged in non-compliant activities or suffered a fall, however this is not confirmed by the patient.The patient was revised two months later.All sequoia screws were removed and an anterior lumbar interbody fusion was performed from l4-s2, skipping the fractured l5 pedicle on the left, with sequoia screws sized up to 6.5 x 45 mm.No further information on postoperative patient conditions or outcome has been reported.

• Brand Name: SEQUOIA TI POLY SCREW ASSY 5.5MM X 40MM
• Type of Device: UOIA TI POLY SCREW ASSY 5.5MM X 40MM
• 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: 5142349
• MDR Text Key: 28036586
• Report Number: 2184052-2015-00102
• 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
• Report Date: 09/15/2015

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 Model Number: 3306-5540
• Device Catalogue Number: 3306-5540
• Device Lot Number: 83EP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 50 YR