MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS 3.5 X 28MM PA SCREW SMOOTH SHANK; SPINAL INTERLAMINAL FIXATION ORTHOSIS.

Catalog Number	48556328
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	08/30/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the surgeon performed an occiput-t2 revision/extension to t3.There was a fractured c1 smooth shank screw (3.5x28mm) in which the tulip head was completely displaced from the shank.During the revision surgery, after gaining access, the surgeon proceeded to remove 18 total blockers from the construct.He verbally noted that multiple blockers were loose upon removal.He then removed both vitallium rods (2 offset connectors included).After removing his rods he had to fish out the screw threading of the c1 smooth shank screw that was fractured.
Additional Manufacturer Narrative
Risk assessment.The device was not returned and no lot # was provided, so a manufacturing record review could not be performed.Per the surgical technique, "delayed union or nonunion: internal fixation appliances are load sharing devices which are used to obtain alignment until normal healing occurs.In the event that healing is delayed, does not occur, or failure to immobilize the delayed/nonunion results, the implant will be subject to excessive and repeated stresses which can eventually cause loosening, bending or fatigue fracture.The degree or success of union, loads produced by weight bearing, and activity levels will, among other conditions, dictate the longevity of the implant.", the surgical technique also states, "while the expected life of spinal implant components is difficult to estimate, it is finite." as the tulip was also found to have disengaged, this further supports the root cause of loading cycles causing the device failure.The most probable root cause of the failure is additional and repetitive stresses placed on the construct from the lack of fusion.
Event or Problem Description
It was reported that the surgeon performed an occiput-t2 revision/extension to t3.There was a fractured c1 smooth shank screw (3.5x28mm) in which the tulip head was completely displaced from the shank.During the revision surgery, after gaining access, the surgeon proceeded to remove 18 total blockers from the construct.He verbally noted that multiple blockers were loose upon removal.He then removed both vitallium rods (2 offset connectors included).After removing his rods he had to fish out the screw threading of the c1 smooth shank screw that was fractured.

• Brand Name: OASYS 3.5 X 28MM 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: 5984102
• Report Number: 0009617544-2016-00383
• Device Sequence Number: 1797091
• Product Code: KWP
• UDI-Device Identifier: 04546540469731
• UDI-Public: (01)04546540469731
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K032394
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2016

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: 48556328
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/28/2016
• Supplement Report FDA Received Date: 11/22/2016
• 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: 72 YR
• Patient Weight: 64