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

Model Number	48551048
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	01/01/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; it¿s alleged by the attorney that the patient was implanted with a plate on (b)(6) 2011 that fractured and required revision in 2014.
Additional Manufacturer Narrative
Method: risk assessment.Result: device history review could not be performed as no lot code was provided.Device evaluation could not be performed as no items were returned.Complaint history review could not be performed as no lot code was provided.Conclusion: the root cause of the reported event could not be determined.
Event or Problem Description
It was reported that; it¿s alleged by the attorney that the patient was implanted with a plate on (b)(6) 2011 that fractured and required revision in 2014.

• Brand Name: OASYS MIDLINE OCCIPUT PLATE ASSY MINI
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6659891
• Report Number: 0009617544-2017-00255
• Device Sequence Number: 750453
• Product Code: KWP
• UDI-Device Identifier: 04546540616579
• UDI-Public: (01)04546540616579
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K151755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2017

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 Model Number: 48551048
• Device Catalogue Number: 48551048
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/26/2017
• Supplement Date Received by Manufacturer: 05/26/2017
• Initial Report FDA Received Date: 06/22/2017
• Supplement Report FDA Received Date: 08/24/2017
• 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