MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND (MDR) XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 45 MM; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number 482316545

Device Problems Fracture (1260); Difficult to Remove (1528); Device Operates Differently Than Expected (2913)

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

Event Date 04/30/2015

Event Type  malfunction  

Event Description

It was reported that the patient came in for a revision and when removing the screw only half of it came out ended up skipping t4 level and extended it through the pelvis.

Manufacturer Narrative

Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: inspection of the device revealed beach marks on the fracture surface, which is consistent with fatigue fracture.Per the ifu, these devices are only meant to provide support during fusion and cannot be expected to indefinitely withstand the loads of normal bone.It was stated that fusion was not achieved.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified conclusion: the most likely cause of the customer reported event is fatigue fracture due to normal loads imposed by the body.

Event Description

It was reported that the patient came in for a revision and when removing the screw only half of it came out ended up skipping t4 level and extended it through the pelvis.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 45 MM
• Type of Device: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND (MDR); le crêt-du-locle 10 a; -; la chaux-de-fonds 02300 ; CH 02300
• Manufacturer (Section G): STRYKER SPINE-SWITZERLAND (MDR); le crêt-du-locle 10 a; -; la chaux-de-fonds 02300 ; CH 02300
• Manufacturer Contact: linford leitch ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 4796422
• MDR Text Key: 5819652
• Report Number: 3005525032-2015-00063
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 482316545
• Device Lot Number: B34676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/30/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/25/2013
• 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