MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA TITANIUM 4.5 POLYAXIAL CROSS CONNECTOR 30-36 MM; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number	48133230
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/11/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; during small surgery, the surgeon inserted the screws to l5 (cbt)-s.And the surgeon tried to use the crosslink connector(medium).But the surgeon could not assembled the crosslink connector.Therefore the surgeon tried to remove the crosslink connector.When the surgeon loosened the center screw of the connector, the screw was deformed.Therefore, the surgeon removed the crosslink connector with the rod.Afterwards, the surgeon used the large crosslink connector.But, the surgeon could not assembled the crosslink connector.Therefore, the surgeon not used the crosslink connector.
Additional Manufacturer Narrative
Complaint history review; risk assessment.Manufacturing records were not reviewed because the lot # of the device was not provided.The device was not returned for evaluation.The root cause cannot be determined because the instruments were not returned and additional information regarding the event was not provided.
Event or Problem Description
It was reported that; during small surgery, the surgeon inserted the screws to l5(cbt)-s.And the surgeon tried to use the crosslink connector(medium).But the surgeon could not assembled the crosslink connector.Therefore the surgeon tried to remove the crosslink connector.When the surgeon loosened the center screw of the connector, the screw was deformed.Therefore the surgeon removed the crosslink connector with the rod.Afterwards, the surgeon used the large crosslink connector.But, the surgeon could not assembled the crosslink connector.Therefore the surgeon not used the crosslink connector.

• Brand Name: XIA TITANIUM 4.5 POLYAXIAL CROSS CONNECTOR 30-36 MM
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5851670
• Report Number: 0009617544-2016-00322
• Device Sequence Number: 1387332
• Product Code: KWP
• UDI-Device Identifier: 04546540515087
• UDI-Public: (01)04546540515087
• Combination Product (Y/N): N
• PMA/510(K) Number: K121342
• 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): 07/11/2016

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: 48133230
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/11/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2016
• Supplement Report FDA Received Date: 10/24/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1