MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW DIA 4.5 X 40 MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	482314540
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Information (3190)
Date of Event	09/27/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that surgeon reported the case of l1 fracture where 4.5 & 5.5 screws have been inserted.When applied the anti turk with tightening of the set screw, the head was broken as in the attached images.During tightening of the set screw it was easy and went in correct direction.The broken screw has been removed.
Additional Manufacturer Narrative
Device history review; complaint history review; risk assessment; manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.An inspection could not be performed as the products were not received.The root cause cannot be determined conclusively.
Event or Problem Description
It was reported that surgeon reported the case of l1 fracture where 4.5 & 5.5 screws have been inserted.When applied the anti turk with tightening of the set screw, the head was broken as in the attached images.During tightening of the set screw it was easy and went in correct direction.The broken screw has been removed.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 4.5 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: 6049029
• Report Number: 3005525032-2016-00134
• Device Sequence Number: 18941018
• Product Code: MNH
• UDI-Device Identifier: 04546540561923
• UDI-Public: (01)04546540561923
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: K071373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2017

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 Catalogue Number: 482314540
• Device Lot Number: B60450
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/21/2016
• Supplement Report FDA Received Date: 01/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1