MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA LP POLYAXIAL SCREW 5.5 X 45MM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Model Number	03821545
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/02/2017
Type of Reportable Event	Malfunction
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 open device agent take nail, needle, the establishment of fluoroscopy location is good, choose screw implant, poor position after perspective.Surgeon removed the screw, found the screw detached and never recovered.
Additional Manufacturer Narrative
No relevant manufacturing issues were identified, as all units met specifications.Excessive force was most likely applied to the implant, causing the tulip to disengage, causing the deformation seen on the implant.Possible cross threading of the screwdriver, difficult angle of the tulip head or inadequate preparation of the pathway are root causes for the user to apply excess force to remove the implant and cause the tulip to disengage.
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.Surgeon removed the screw, found the screw detached and never recovered.

• Brand Name: XIA LP POLYAXIAL SCREW 5.5 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: 7199493
• Report Number: 3005525032-2018-00003
• Device Sequence Number: 1173312
• Product Code: KWQ
• UDI-Device Identifier: 04546540149183
• UDI-Public: (01)04546540149183
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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): 03/28/2018

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: 03821545
• Device Catalogue Number: 03821545
• Device Lot Number: B72020
• 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: 02/27/2018
• Initial Report FDA Received Date: 01/17/2018
• Supplement Report FDA Received Date: 03/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1