MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS 3.5X34MM POLYAXIAL SCREW; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number	48552334
Medical Device Problem Codes	Mechanical Problem (1384); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	03/29/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; there were separation (head and screw) of polyaxial screw 2 times after screw implant operation.Screws were operated fixation to cervical 1 and 2 on (b)(6) of feb.There was no abnormal during routine x-ray check-up.1 month later, breakaway of the screw from its head was detected on x-ray among one of implanted polyaxial screw to c1.So 2nd operation was conducted (remove defeat part and fix new one), then another breakaway was found for implanted screw to c2 during routine x-ray check-up.Next day, 3rd operation was conducted (removed defeat part and fix new one).
Additional Manufacturer Narrative
Risk assessment; device inspection, complaint review, manufacturing review and device history review was not performed because no parts were returned and no lot# provided.The plausible root cause cannot be determined conclusively because device was not returned for evaluation.
Event or Problem Description
It was reported that; there were separation (head and screw) of polyaxial screw 2 times after screw implant operation.Screws were operated fixation to cervical 1 and 2 on (b)(6).There was no abnormal during routine x-ray check-up.One month later, breakaway of the screw from its head was detected on x-ray among one one of implanted polyaxial screw to c1.So 2nd operation was conducted (remove defeat part and fix new one), then another breakaway was found for implanted screw to c2 during routine x-ray check-up.Next day, 3rd operation was conducted (removed defeat part and fix new one).

• Brand Name: OASYS 3.5X34MM 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: 6525468
• Report Number: 0009617544-2017-00178
• Device Sequence Number: 16476571
• Product Code: KWP
• UDI-Device Identifier: 07613154111725
• UDI-Public: (01)07613154111725
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K151755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2017

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 Catalogue Number: 48552334
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/30/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/27/2017
• Supplement Report FDA Received Date: 06/06/2017
• 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
• Patient Age: 25 YR