MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 60 MM; PEDICLE SCREW SPINAL SYSTEM.

Model Number	482316560
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Pain (1994); Skin Irritation (2076); Injury (2348)
Date of Event	04/19/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; on (b)(6) 2012, surgery was performed (left: l3-l5, right: l3-iliac).After the surgery the patient complained pain because s2ai screw was irritating the skin.Further the surgeon found the breakage of the right s2ai screw.On (b)(6) 2017, the extraction surgery was performed.The broken screw tip did not be removed and remained to the patient.
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.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified conclusion: the definitive root cause of the event could not be determined from given information.
Event or Problem Description
It was reported that; on (b)(6) 2012, surgery was performed (left: l3-l5, right: l3-iliac).After the surgery the patient complained pain because s2ai screw was irritating the skin.Further the surgeon found the breakage of the right s2ai screw.On (b)(6) 2017, the extraction surgery was performed.The broken screw tip did not be removed and remained to the patient.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 60 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: 6567277
• Report Number: 3005525032-2017-00056
• Device Sequence Number: 926073
• Product Code: MNH
• UDI-Device Identifier: 04546540562272
• UDI-Public: (01)04546540562272
• Combination Product (Y/N): N
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2017

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 Model Number: 482316560
• Device Catalogue Number: 482316560
• Device Lot Number: B14872
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/19/2017
• Supplement Date Received by Manufacturer: 04/19/2017
• Initial Report FDA Received Date: 05/15/2017
• Supplement Report FDA Received Date: 08/24/2017
• 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
• Patient Age: 82 YR
• Patient Weight: 50