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	Fall (1848); Injury (2348)
Date of Event	07/29/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient fell and the rod and blockers separated from occipital plate.Put a competitive plate on and reattached to same screws.
Additional Manufacturer Narrative
Catalog# 48551000.Method: visual inspection, device history review; complaint history review; risk assessment.Results: manufacturing files were reviewed and no incidents were found.The rep did not provide any additional information on the patient's health and bone quality, however the patient was reported to have experienced a fall.Conclusion: the probable root cause is the reported fall that the patient experienced.
Event or Problem Description
It was reported that the patient fell and the rod and blockers separated from occipital plate.Put a competitive plate on and reattached to same screws.

• 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: 5901015
• Report Number: 0009617544-2016-00346
• Device Sequence Number: 815164
• Product Code: KWP
• UDI-Device Identifier: 04546540616531
• UDI-Public: (01)04546540616531
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 48551000
• Device Lot Number: PUV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2016
• Supplement Report FDA Received Date: 10/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 44