MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA LP POLYAXIAL SCREW 6.5 X 40MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number 03821640

Device Problems Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395); Defective Device (2588)

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

Event Date 08/25/2016

Event Type  malfunction  

Event Description

It was reported that; the complaint alleges a medical defect involving a bone graft.Update: it was also discovered that the patient had migration of the cage, and loosening of screws.

Manufacturer Narrative

Patient identifier: (b)(6).Catalog# 03821640.Lot# b43986.Date of implant: (b)(6) 2014.Date of explant: (b)(6) 2014.Method: device history review, complaint history review, risk assessment; result: device history review indicated all devices released into final stock met specifications.Device evaluation could not be performed as no items were returned.Complaint history review indicated there have been no other similar complaints for this reported lot.Conclusion: the event could not be confirmed nor the root cause of the reported event determined because no device and/or insufficient information was provided for review.

Event Description

It was reported that; the complaint alleges a medical defect involving a bone graft.Update: it was also discovered that the patient had migration of the cage, and loosening of screws.

• Brand Name: XIA LP POLYAXIAL SCREW 6.5 X 40MM
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• Manufacturer (Section G): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• Manufacturer Contact: rakshya bista ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5972866
• MDR Text Key: 55793387
• Report Number: 3005525032-2016-00116
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 03821640
• Device Lot Number: B43986
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2014
• 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