MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA LP POLYAXIAL SCREW 6.5 X 45MM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.

Catalog Number	03821645
Medical Device Problem Codes	Detachment Of Device Component (1104); Mechanical Problem (1384)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	12/26/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported that 5 years ago, the products were implanted in the patient.After that, the products were attempted to be removed on (b)(6) 2016 after synostotic.A broken screw was confirmed after removing the screw from area of s1 r.The broken part couldn't be removed and in patient body.And attempted to remove the screw of l5 l, it was rocked the head of screw.It was confirmed the broken screw head was on the tip of a monodriver during unlocking the screw by the monodriver.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment; results: screw tulip disengagement was confirmed via visual inspection.No relevant manufacturing issues were identified as all units met stryker specifications.Conclusion: the most likely cause of the event is fatigue of the devices due to the length of implantation.
Event or Problem Description
It is reported that 5 years ago, the products were implanted in the patient.After that, the products were attempted to be removed on (b)(6) 2016 after synostotic.A broken screw was confirmed after removing the screw from area of s1 r.The broken part couldn't be removed and in patient body.And attempted to remove the screw of l5 l, it was rocked the head of screw.It was confirmed the broken screw head was on the tip of a mono driver during unlocking the screw by the mono driver.

• Brand Name: XIA LP POLYAXIAL SCREW 6.5 X 45MM
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 6277941
• Report Number: 3005525032-2017-00014
• Device Sequence Number: 16327991
• Product Code: KWQ
• UDI-Device Identifier: 04546540149244
• UDI-Public: (01)04546540149244
• Combination Product (Y/N): N
• PMA/510(K) Number: K002858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 03821645
• Device Lot Number: A82643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/25/2017
• Supplement Report FDA Received Date: 04/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1