MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 45 MM; PEDICLE SCREW SPINAL SYSTEM.

Model Number	482316545
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Injury (2348); Device Embedded In Tissue or Plaque (3165)
Date of Event	04/24/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device was implanted on (b)(6) 2015.On (b)(6) 2017, it was removed the broken the screw, but the tip of broken screw was remained in patient.At the time of initial surgical procedure, it was assumed a possibility of breakage screw.
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, risk assessment; result: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Visual inspection for the device showed that the screw was fractured at the thread body.Conclusion: the root cause of the event cannot be determined with the given information.
Event or Problem Description
It was reported that the device was implanted on (b)(6) 2015.On (b)(6) 2017, it was removed the broken the screw, but the tip of broken screw was remained in patient.At the time of initial surgical procedure, it was assumed a possibility of breakage screw.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 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: 6579430
• Report Number: 3005525032-2017-00060
• Device Sequence Number: 97660
• Product Code: MNH
• UDI-Device Identifier: 04546540562241
• UDI-Public: (01)04546540562241
• Combination Product (Y/N): N
• PMA/510(K) Number: K083393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2017

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: 482316545
• Device Catalogue Number: 482316545
• Device Lot Number: B47725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2017
• Initial Date Received by Manufacturer: 04/24/2017
• Supplement Date Received by Manufacturer: 04/24/2017
• Initial Report FDA Received Date: 05/19/2017
• Supplement Report FDA Received Date: 07/21/2017
• 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