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

Model Number	482378580
Medical Device Problem Codes	Detachment Of Device Component (1104); Mechanical Problem (1384)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	04/20/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: primary surgery for scoliosis was performed on (b)(6) 2011 and l1-5 were fixed with.After that, the fixation was extended to iliac and the rods were added because the scoliosis had progressed on (b)(6) 2012.Then, the rod breakage at l3/4 was found and revision surgery was performed on (b)(6) 2017.In the revision surgery, pso of l3 was performed.The screws were remained, the blockers and rods were replaced to new articles.At that time, the loosening of the blockers of the iliac screws were confirmed.
Additional Manufacturer Narrative
Method: device history review; complaint history review; risk assessment; results: visual, dimensional and functional analysis could not be performed as the device was not returned.No relevant manufacturing issues were identified as all units met stryker specifications.Conclusion: the definite root cause cannot be determined.
Event or Problem Description
It was reported that; primary surgery for scoliosis was performed on (b)(6) 2011 and l1-5 were fixed with.After that, the fixation was extended to iliac and the rods were added because the scoliosis had progressed on (b)(6) 2012.Then, the rod breakage at l3/4 was found and revision surgery was performed on (b)(6) 2017.In the revision surgery, pso of l3 was performed.The screws were remained, the blockers and rods were replaced to new articles.At that time, the loosening of the blockers of the iliac screws were confirmed.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW CLOSED HEAD 8.5 X 80MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 6589700
• Report Number: 3005525032-2017-00063
• Device Sequence Number: 16330226
• Product Code: MNI
• UDI-Device Identifier: 07613327001198
• UDI-Public: (01)07613327001198
• Combination Product (Y/N): N
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2017

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 Model Number: 482378580
• Device Catalogue Number: 482378580
• Device Lot Number: B42307
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/26/2017
• Supplement Date Received by Manufacturer: 04/26/2017
• Initial Report FDA Received Date: 05/24/2017
• Supplement Report FDA Received Date: 07/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR