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

Model Number	48551045
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	12/30/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tulip heads broke off of the medium occipital plate.A replacement plate was implanted.
Additional Manufacturer Narrative
The reported event resulted in revision surgery for the patient.The possible root causes include: -improper construct, set screws not tightened correctly, -excessive load due to unstable construct, -excessive load due to patient anatomy/pathology, -patient performs strenuous post-op activities, -surgeon applying too much torque to seat the screw head.
Event or Problem Description
It was reported that the tulip heads broke off of the medium occipital plate.A replacement plate was implanted.

• 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: 7218063
• Report Number: 0009617544-2018-00019
• Device Sequence Number: 11357332
• Product Code: KWP
• UDI-Device Identifier: 04546540616548
• UDI-Public: (01)04546540616548
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093670
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2018

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: 48551045
• Device Catalogue Number: 48551045
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/30/2017
• Supplement Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 01/25/2018
• Supplement Report FDA Received Date: 03/29/2018
• 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: 70 YR
• Patient Weight: 93