MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 PEDICLE MARKERS (SET OF 6); ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Model Number	48237081
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported that the pedicle marker broke off into the pedicle of r l3 vertebrae.Surgeon believes the proximal end of marker got caught on retractor causing it to break off into patient.No adverse consequences to the patient and no delay is reported.
Event or Problem Description
It is reported that the pedicle marker broke off into the pedicle of r l3 vertebrae.Surgeon believes the proximal end of marker got caught on retractor causing it to break off into patient.No adverse consequences to the patient and no delay is reported.

• Brand Name: XIA 3 PEDICLE MARKERS (SET OF 6)
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7322755
• Report Number: 0009617544-2018-00063
• Device Sequence Number: 18993969
• Product Code: LXH
• UDI-Device Identifier: 07613327265590
• UDI-Public: (01)07613327265590
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 05/17/2018

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: Health Professional
• Device Model Number: 48237081
• Device Catalogue Number: 48237081
• Device Lot Number: 10G787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Initial Date Received by Manufacturer: 02/13/2018
• Supplement Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 03/07/2018
• Supplement Report FDA Received Date: 05/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1