MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM MONOAXIAL SCREW DIA 6.5 X 40 MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	482306540
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Injury (2348); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/01/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; screws were implanted (b)(6) 2015, surgeon became aware of broken screw at end of the construct on scoliosis fusion case.
Additional Manufacturer Narrative
Risk assessment; visual, analysis, device history and functional analysis could not be performed as the device was not returned.No lot # was provided, so a manufacturing record review could not be performed.The definitive root cause of the event could not be determined from given information.
Event or Problem Description
It was reported that; screws were implanted (b)(6) 2015, surgeon became aware of broken screw at end of the construct on scoliosis fusion case.

• Brand Name: XIA 3 TITANIUM MONOAXIAL SCREW DIA 6.5 X 40 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: 6219890
• Report Number: 3005525032-2017-00001
• Device Sequence Number: 16208676
• Product Code: MNH
• UDI-Device Identifier: 04546540561497
• UDI-Public: (01)04546540561497
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K1136666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• 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: 482306540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/03/2017
• 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
• Patient Age: 17 YR