MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND (MDR) XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 80MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number 482318580

Device Problems Mechanical Problem (1384); Device Inoperable (1663)

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

Event Date 06/23/2015

Event Type  malfunction  

Event Description

It was reported that; a screw and 3 blockers failed to lock down properly.Reason unknown.

Manufacturer Narrative

(b)(4).Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The returned pa screw was attempted to be assembled with a blocker could not be.The inspection revealed deformation on the threads as well as discoloration.Furthermore, the tulip was confirmed to be splayed.Both of these conditions suggest that the initial blocker inserted was cross threaded.This is supported by the deformation observed on one of the returned blockers.Conclusion: the most likely cause of the customer reported event is improper insertion of the blocker leading to cross threading and deformation of the tulip threads.

Event Description

It was reported that; a screw and 3 blockers failed to lock down properly.Reason unknown.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 80MM
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND (MDR); le crêt-du-locle 10 a; -; la chaux-de-fonds 02300 ; SZ 02300
• Manufacturer (Section G): STRYKER SPINE-SWITZERLAND (MDR); le crêt-du-locle 10 a; -; la chaux-de-fonds 02300 ; SZ 02300
• Manufacturer Contact: linford leitch ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 4921782
• MDR Text Key: 22462338
• Report Number: 3005525032-2015-00085
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Report Date: 06/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 482318580
• Device Lot Number: B53317
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2015
• 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