MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA 3 TITANIUM MULTIAXIAL CROSSLINK 35MM 44MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number 48236035

Device Problem Positioning Problem (3009)

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

Event Date 06/19/2015

Event Type  malfunction  

Event Description

It was reported that; during surgery, the one side set screw of the crosslink could not be turn.The surgeon used other crosslink and finished the surgery.

Manufacturer Narrative

Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: the returned connector was confirmed to have a jammed set screw.This was likely the result of the set screw being fully backed out past the acceptable position.However, the screw was torqued back to a usable position and was then found to be fully functional.No relevant manufacturing issues were identified during manufacturing record review.Conclusion: the most likely cause of the customer reported event is the customer fully backing out the set screw past its usable position, which resulted in its jamming.

Event Description

It was reported that; during surgery, the one side set screw of the crosslink could not be turn.The surgeon used other crosslink and finished the surgery.

• Brand Name: XIA 3 TITANIUM MULTIAXIAL CROSSLINK 35MM 44MM
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: linford leitch ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 4916579
• MDR Text Key: 22392691
• Report Number: 0009617544-2015-00325
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K113666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Report Date: 06/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 48236035
• Device Lot Number: 152411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2015
• 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