MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 50MM; PEDICLE SCREW SPINAL SYSTEM

Model Number	482318550
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/19/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; during l5-s tlif surgery, the screw head detached from the screw shaft while the final tightening of s1 right screw.Then the surgeon replace the screw and finished the surgery without problem.
Additional Manufacturer Narrative
Lot#: b70963.
Event or Problem Description
It was reported that; during l5-s tlif surgery, the screw head detached from the screw shaft while the final tightening of s1 right screw.Then the surgeon replace the screw and finished the surgery without problem.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 50MM
• 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: 6567328
• Report Number: 3005525032-2017-00058
• Device Sequence Number: 788874
• Product Code: MNI
• UDI-Device Identifier: 04546540598608
• UDI-Public: (01)04546540598608
• Combination Product (Y/N): N
• PMA/510(K) Number: K083393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2017

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: 482318550
• Device Catalogue Number: 482318550
• Device Lot Number: B70963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2017
• Initial Date Received by Manufacturer: 04/19/2017
• Supplement Date Received by Manufacturer: 04/19/2017
• Initial Report FDA Received Date: 05/15/2017
• Supplement Report FDA Received Date: 09/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR