MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS BLOCKER; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number	48551000
Medical Device Problem Codes	Mechanical Problem (1384); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	02/08/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon found the loosening of the blocker upon x-ray images.Therefore, the surgeon is monitoring the patient, and is planning revision surgery.
Additional Manufacturer Narrative
Catalog# 48551000, lot# ln9.Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: manufacturing files were reviewed and no incidents were found.The returned blockers showed evidence of contact with a rod.Conclusion: the likely root cause is not determined due to lack of details available.
Event or Problem Description
It was reported that the surgeon found the loosening of the blocker upon x-ray images.Therefore, the surgeon is monitoring the patient, and is planning revision surgery.

• Brand Name: OASYS BLOCKER
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5478038
• Report Number: 0009617544-2016-00089
• Device Sequence Number: 301022
• Product Code: KWP
• UDI-Device Identifier: 04546540380524
• UDI-Public: 04546540380524
• Combination Product (Y/N): N
• PMA/510(K) Number: K151755
• 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): 02/08/2016

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: 48551000
• Device Lot Number: 09A640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/03/2016
• Supplement Report FDA Received Date: 05/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1