MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA LP POLYAXIAL SCREW 6.5 X 40MM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Model Number	03821640
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	12/01/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; patient was put in prone position.This was a regular operation sterilization spread towels, full clear surgical field exposure, conventional cone, open device agent take nail, needle, the establishment of fluoroscopy location is good, choose screw implant, poor position after perspective, remove the screw, the book found the screw angle is fixed and cannot be restored.
Additional Manufacturer Narrative
The customer reported event was confirmed via visual inspection.The tulip head was overextended over the screw shank head to one side and was jammed.Polyaxiality of the screw was lost.A manufacturing review found no relevant manufacturing issues as all units met stryker specifications.It was reported that the tulip head was jammed after removing the screw because of poor screw placement.Conclusion: as the tulip head was found overextended on the screw shank to one side, the most likely root cause is off axis loading to one side was applied to the screw during removal, causing the tulip to overextend to that side and lose polyaxiality.
Event or Problem Description
It was reported that; patient was put in prone position.This was a regular operation sterilization spread towels, full clear surgical field exposure, conventional cone, open device agent take nail, needle, the establishment of fluoroscopy location is good, choose screw implant, poor position after perspective, remove the screw, the book found the screw angle is fixed and cannot be restored.There was a reported delay of 20-30 minutes.

• Brand Name: XIA LP POLYAXIAL SCREW 6.5 X 40MM
• 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: 7203677
• Report Number: 3005525032-2018-00004
• Device Sequence Number: 164187
• Product Code: KWQ
• UDI-Device Identifier: 04546540149237
• UDI-Public: (01)04546540149237
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K060361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 03821640
• Device Catalogue Number: 03821640
• Device Lot Number: B67352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Initial Date Received by Manufacturer: 12/21/2017
• Supplement Date Received by Manufacturer: 03/26/2018
• Initial Report FDA Received Date: 01/18/2018
• Supplement Report FDA Received Date: 04/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other