MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA DEFORMITY UNIPLANAR SCREW REDUCTION DIA 5.5 X 50MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	482365550
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/18/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the 5.5 uniplanar reduction tulip, separated from the thread shaft during removal of the temporary rod.Update (20-april-2016): the temporary rod holds everything in position and helps when putting a rod in one side.The temporary rod is a small rod (6in) put in one side and the permanent rod is placed on other side.It acts like a brace for when putting the rod on the adjacent side.It is implanted temporarily for 15-20min and once correction is done they remove the temp rod and replace with permanent rod.All happens during the same procedure.Issue was noticed during removal of the temp rod.Tulip head was off the threaded part was still in the body and they took the driver and took it out.No delay.No adverse consequences.
Additional Manufacturer Narrative
Results: the device was inspected and found that the tulip head was disengaged from the screw body.There was deformity on the tulip head locking clip as well as the head of the screw thread body.This maybe due to use of excessive reduction force applied during use with the temporary rod.Which in turn lead to tulip disengagement during removal of temp rod.Conclusion: the possible root cause of the event is determined to be excessive reduction force applied leading to tulip disengagement.
Event or Problem Description
It was reported that; the 5.5 uniplanar reduction tulip, separated from the thread shaft during removal of the temporary rod.Update (20-april-2016): the temporary rod holds everything in position and helps when putting a rod in one side.The temporary rod is a small rod (6in) put in one side and the permanent rod is placed on other side.It acts like a brace for when putting the rod on the adjacent side.It is implanted temporarily for 15-20min and once correction is done they remove the temp rod and replace with permanent rod.All happens during the same procedure.Issue was noticed during removal of the temp rod.Tulip head was off the threaded part was still in the body and they took the driver and took it out.No delay.No adverse consequences.

• Brand Name: XIA DEFORMITY UNIPLANAR SCREW REDUCTION DIA 5.5 X 50MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5648315
• Report Number: 0009617544-2016-00184
• Device Sequence Number: 18880832
• Product Code: MNH
• UDI-Device Identifier: 04546540602039
• UDI-Public: (01)04546540602039
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2016

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: 482365550
• Device Lot Number: 162660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/11/2016
• Supplement Report FDA Received Date: 09/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1