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

Model Number	482318550
Medical Device Problem Codes	Mechanical Problem (1384); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	10/26/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; l5 / s1 by plif was performed.When applying compression on the left side temporarily fixed with a rod, the head of l5 is compressing, the position of the head moves considerably and then when trying to fasten the final tightening with a torque wrench the left side of l5 idles and the head moves.Therefore, once the blocker and rod are removed, the head detaches.For that reason, the screw was replaced with 8.5 x 50 mm of the same size, compression was performed and final tightening.When the damaged screw was confirmed, the washer built in the head worn out and was partially damaged.In addition, part of the six pointer was also damaged.
Additional Manufacturer Narrative
The screw was returned in 2 pieces as the tulip head was disengaged from the screw body.No relevant manufacturing issues were identified as all units met specifications.Conclusion: the root cause is excessive force applied by the user.
Event or Problem Description
It was reported that; l5/s1 by plif was performed.When applying compression on the left side temporarily fixed with a rod, the head of l5 is compressing, the position of the head moves considerably and then when trying to fasten the final tightening with a torque wrench the left side of l5 idles and the head moves.Therefore, once the blocker and rod are removed, the head detaches.For that reason, the screw was replaced with 8.5 x 50 mm of the same size, compression was performed and final tightening.When the damaged screw was confirmed, the washer built in the head worn out and was partially damaged.In addition, part of the six pointer was also damaged.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 50MM
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 7049716
• Report Number: 3005525032-2017-00105
• Device Sequence Number: 13792647
• Product Code: KWP
• 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
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2018

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: B66058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2017
• Initial Date Received by Manufacturer: 10/26/2017
• Supplement Date Received by Manufacturer: 10/26/2017
• Initial Report FDA Received Date: 11/21/2017
• Supplement Report FDA Received Date: 01/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1