MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW DIA 5.5 X 30 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482315530
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	09/12/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the metal was being removed, 3 screws showed were broken.Not enough cement was pressed into cartridge.No further implants were implanted into patient because healing is needed first.The 3 broken devices stay in the patient.
Additional Manufacturer Narrative
Method: risk assessment; results: visual, dimensional and functional analysis could not be performed as the device was not returned.No relevant manufacturing issues were identified as all units met specifications.Conclusion: the definitive root cause of the event cannot be determined as device is not available for inspection.
Event or Problem Description
It was reported that when the metal was being removed, 3 screws showed were broken.Not enough cement was pressed into cartridge.No further implants were implanted into patient because healing is needed first.The 3 broken devices stay in the patient.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 5.5 X 30 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 6932433
• Report Number: 3005525032-2017-00097
• Device Sequence Number: 788107
• Product Code: MNI
• UDI-Device Identifier: 04546540562029
• UDI-Public: (01)04546540562029
• Combination Product (Y/N): N
• PMA/510(K) Number: K071373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2017

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: 482315530
• Device Catalogue Number: 482315530
• Device Lot Number: B46811
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/15/2017
• Supplement Date Received by Manufacturer: 09/15/2017
• Initial Report FDA Received Date: 10/09/2017
• Supplement Report FDA Received Date: 12/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1