MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS MIDLINE OCCIPUT PLATE ASSY MEDIUM; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number	48551045
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	11/13/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a tulip head attached to a leg of the plate detached maintaining rod and blocker.
Additional Manufacturer Narrative
Age at the time of event: (b)(6).Method: visual inspection;device history review; complaint history review; risk assessment.Results: the returned device was confirmed visually to have to have both tulip pins to plate fractured.Manufacturing records were reviewed due and no anomalies were found.Conclusion: the probable root causes of the tulip fracture is non-union from occipital to c2 (c1 to c2).
Event or Problem Description
It was reported that a tulip head attached to a leg of the plate detached maintaining rod and blocker.

• Brand Name: OASYS MIDLINE OCCIPUT PLATE ASSY MEDIUM
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5486597
• Report Number: 0009617544-2016-00105
• Device Sequence Number: 272137
• Product Code: KWP
• UDI-Device Identifier: 04546540616548
• UDI-Public: (01)04546540616548
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K093670
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2016

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: 48551045
• Device Lot Number: 14C503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2016
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Weight: 68