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

Catalog Number	482316545
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	05/13/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; broken screws discovered upon revision surgery.Two screws were discovered to be fractured through the mid-shaft of the screw.Issue was noticed during imaging and confirmed when the screws were removed.Screws were replaced in the revision surgery.The broken screws were not the primary reason for the revision.The primary reason for the revision surgery was adjacent level disease at l2-3.Update 16-may-2016: ct images of broken screws available.
Additional Manufacturer Narrative
Method: complaint history review; risk assessment.Results: no lot # was provided, so a manufacturing record review could not be performed.The device has not been returned for inspection, the activity level of the patient is unknown.It is unknown if the patient experienced any fall and the date of initial surgery is not known.Conclusion: the root cause of the event could not be determined with the given information.
Event or Problem Description
It was reported that; broken screws discovered upon revision surgery.Two screws were discovered to be fractured through the mid-shaft of the screw.Issue was noticed during imaging and confirmed when the screws were removed.Screws were replaced in the revision surgery.The broken screws were not the primary reason for the revision.The primary reason for the revision surgery was adjacent level disease at l2-3.Update - (b)(6) 2016: ct images of broken screws available.

• 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: 5707555
• Report Number: 3005525032-2016-00063
• Device Sequence Number: 16184411
• Product Code: MNI
• UDI-Device Identifier: 04546540562241
• UDI-Public: (01)04546540562241
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2016

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: 482316545
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/08/2016
• Supplement Report FDA Received Date: 10/10/2016
• 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: Other