MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS 3.5 X 22MM PA SCREW SMOOTH SHANK; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Model Number	48556322
Medical Device Problem Codes	Mechanical Problem (1384); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/19/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; c1 smooth shank screw head (on the patient's right) has become separated from the screw thread postoperatively while patient in collar.Update (b)(6): there is no planned revision at this time.The contralateral construct is holding.
Additional Manufacturer Narrative
Method: x-rays, risk assessment.Results: no results available since no evaluation was performed.No lot # was provided, so a manufacturing record review could not be performed.Conclusion: the definitive root cause of the event cannot be determined from the given information.
Event or Problem Description
It was reported that; c1 smooth shank screw head (on the patient's right) has become separated from the screw thread postoperatively while patient in collar.Update 10/12/2017: there is no planned revision at this time.The contralateral construct is holding.

• Brand Name: OASYS 3.5 X 22MM PA SCREW SMOOTH SHANK
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6954468
• Report Number: 0009617544-2017-00376
• Device Sequence Number: 1111722
• Product Code: KWP
• UDI-Device Identifier: 04546540469700
• UDI-Public: (01)04546540469700
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2018

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: 48556322
• Device Catalogue Number: 48556322
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/20/2017
• Supplement Date Received by Manufacturer: 09/20/2017
• Initial Report FDA Received Date: 10/17/2017
• Supplement Report FDA Received Date: 01/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 76