MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA 3 TITANIUM MULTIAXIAL CROSSLINK 30MM 35MM; PEDICLE SCREW SPINAL SYSTEM

Model Number	48236030
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/20/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; upon going to use several cross links on a long construct it became evident that several of the set screws had become dethreaded from the cross links itself.Typically we can thread these back in, weaver with this particular batch, it appeared as thought all were "damaged" or otherwise affected to the point where we could no longer get the set screw back into place.
Additional Manufacturer Narrative
Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The product has not been returned and is unavailable for evaluation.The plausible root cause of the device cannot be determined.
Event or Problem Description
It was reported that; upon going to use several cross links on a long construct it became evident that several of the set screws had become dethreaded from the cross links itself.Typically we can thread these back in, weaver with this particular batch, it appeared as thought all were "damaged" or otherwise affected to the point where we could no longer get the set screw back into place.

• Brand Name: XIA 3 TITANIUM MULTIAXIAL CROSSLINK 30MM 35MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6723512
• Report Number: 0009617544-2017-00289
• Device Sequence Number: 1236612
• Product Code: MNH
• UDI-Device Identifier: 04546540560858
• UDI-Public: (01)04546540560858
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2017

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: 48236030
• Device Catalogue Number: 48236030
• Device Lot Number: 14E137
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/20/2017
• Supplement Date Received by Manufacturer: 06/20/2017
• Initial Report FDA Received Date: 07/18/2017
• Supplement Report FDA Received Date: 09/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1