MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 VITALIUM ROD WITH HEX 6.0MM X 600MM; PEDICLE SCREW SPINAL SYSTEM.

Catalog Number	48232601
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/04/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgery, the rod broke when the surgeon was bending it.After that the surgeon used another rod and finished the surgery.
Additional Manufacturer Narrative
Visual analysis, device history review, complaint history review, risk assessment; the returned rod was confirmed to have fractured at the laser marking dot, which was observed to have voids during inspection.No relevant manufacturing issues were identified.The most likely cause of the customer reported event is the presence of voids on the laser marking dots, which were positioned on the tensile side of the rod bend.
Event or Problem Description
It was reported that during a surgery, the rod broke when the surgeon was bending it.After that the surgeon used another rod and finished the surgery.

• Brand Name: XIA 3 VITALIUM ROD WITH HEX 6.0MM X 600MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM.
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 5531901
• Report Number: 3005525032-2016-00029
• Device Sequence Number: 224707
• Product Code: NKB
• UDI-Device Identifier: 04546540608642
• UDI-Public: (01)04546540608642
• Combination Product (Y/N): N
• 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): 03/04/2016

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: 48232601
• Device Lot Number: MAD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/04/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/29/2016
• Supplement Report FDA Received Date: 10/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 79