MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA 3 PROBE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	IS2739XLP01
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	07/06/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgery, the tip of the probe was broken about 8 mm from the tip when it was inserted to th10 left.The broken part was remained to the patient.The case was l1 burst fracture, th10-l3 were fixed.The surgeon is worried about the influence when mri examination is performed.
Event or Problem Description
It was reported that during a surgery, the tip of the probe was broken about 8 mm from the tip when it was inserted to th10 left.The broken part was remaind to the patient.The case was l1 burst fracture, th10-l3 were fixed.The surgeon is worried about the influence when mri examination is performed.Update (b)(6) 2017: a literature search was conducted to evaluate the potential for magnetic field interactions for spinal implants of varying materials (including stainless steel) and demonstrated safety in defined magnetic resonance conditions.No adverse events related to mri procedures have been reported for spine implants.

• Brand Name: XIA 3 PROBE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas NJ 33610 ; FR 33610
• MDR Report Key: 6755679
• Report Number: 3004024955-2017-00032
• Device Sequence Number: 1115799
• Product Code: LXH
• UDI-Device Identifier: 07613327279313
• UDI-Public: (01)07613327279313
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2017

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 Catalogue Number: IS2739XLP01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Initial Date Received by Manufacturer: 07/06/2017
• Supplement Date Received by Manufacturer: 07/06/2017
• Initial Report FDA Received Date: 07/31/2017
• Supplement Report FDA Received Date: 10/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1