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 Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/06/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; surgeon was bending a plate, when bending on one of the legs it snapped.Bending with benders that come with the device.Peformed over the patient.All broken fragments retrieved no fragments fell into the cavity.
Additional Manufacturer Narrative
The possible root causes include: plate bending too acute and notching of plate by bending irons.The exact cause could not be determined.
Event or Problem Description
It was reported that; surgeon was bending a plate, when bending on one of the legs it snapped.Bending with benders that come with the device.Performed over the patient.All broken fragments retrieved no fragments fell into the cavity.Another plate was used to complete the procedure.There was no surgical delay or adverse health consequences.

• 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: 7150881
• Report Number: 0009617544-2017-00446
• Device Sequence Number: 16398276
• Product Code: KWP
• UDI-Device Identifier: 04546540616548
• UDI-Public: (01)04546540616548
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 48551045
• Device Catalogue Number: 48551045
• Device Lot Number: 145697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2017
• Initial Date Received by Manufacturer: 12/06/2017
• Supplement Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 12/28/2017
• 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
• Patient Age: 75 YR