MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 45 MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	482317545
Medical Device Problem Codes	Detachment Of Device Component (1104); Mechanical Problem (1384)
Health Effect - Clinical Codes	Injury (2348); No Information (3190)
Date of Event	09/12/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; the screw tulip head popped off of left l4 screw 3 days post op.Original surgery was (b)(6).L3-l5 posterior fusion.L4 screw was removed and not replaced.The broken screw has been sent to pathology and will be released sometime within the next 2 weeks.At that point i will ship back to stryker.
Additional Manufacturer Narrative
Method: device history review; complaint history review; risk assessment; results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Visual, dimensional and functional analysis could not be performed as the device was not returned.Conclusion: the definitive root cause of the event cannot be determined with the given information.
Event or Problem Description
It was reported that; the screw tulip head popped off of left l4 screw 3 days post op.Original surgery was (b)(6).L3-l5 posterior fusion.L4 screw was removed and not replaced.The broken screw has been sent to pathology and will be released sometime within the next 2 weeks.At that point i will ship back to stryker.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 45 MM
• 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: 6004504
• Report Number: 3005525032-2016-00124
• Device Sequence Number: 18851561
• Product Code: MNI
• UDI-Device Identifier: 04546540562357
• UDI-Public: (01)04546540562357
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2017

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 Catalogue Number: 482317545
• Device Lot Number: B13101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/06/2016
• Supplement Report FDA Received Date: 05/24/2017
• 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: Required Intervention