MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS 3.5X30MM POLYAXIAL SCREW; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Model Number	48552330
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/26/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; after the completion of the surgical nail, screw the screw spike from the nail head.
Additional Manufacturer Narrative
Additional supplemental will be submitted upon completion of investigation.
Event or Problem Description
It was reported that; after the completion of the surgical nail, the screw detached from the nail head.

• Brand Name: OASYS 3.5X30MM POLYAXIAL SCREW
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6976236
• Report Number: 0009617544-2017-00381
• Device Sequence Number: 11062095
• Product Code: KWP
• UDI-Device Identifier: 07613154129867
• UDI-Public: (01)07613154129867
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K151755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2017

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: 48552330
• Device Catalogue Number: 48552330
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/27/2017
• Supplement Date Received by Manufacturer: 09/27/2017
• Initial Report FDA Received Date: 10/25/2017
• Supplement Report FDA Received Date: 10/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR