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

Model Number	48556328
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	10/24/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the post op images show a rod that has is not connected to the screw.Additional information: "the revision surgery has not occurred yet, it is scheduled for (b)(6).".
Additional Manufacturer Narrative
Additional follow up will be provided once investigation is completed.
Event or Problem Description
It was reported that the post op images show a rod that has is not connected to the screw.Additional information: "the revision surgery occured on (b)(6).
Additional Manufacturer Narrative
Lot #: 091832.Method: x-rays, device history review, complaint history review, risk assessment.Result: the customer reported that a screw was removed because one had a tulip popped out.Manufacturing records were reviewed and no anomalies were found.Conclusion: the plausible root cause cannot be determined conclusively because device was not returned for evaluation.Potential root causes may be: improper construct, set screws not tightened correctly.Excessive load due to unstable construct.Excessive load due to patient anatomy/pathology.Patient performs strenuous post-op activities.Surgeon applying too much torque to seat the screw head.
Event or Problem Description
It was reported that the post op images show a rod that has is not connected to the screw.Additional information: "the revision surgery occurred on (b)(6).

• Brand Name: OASYS 3.5 X 28MM PA SCREW SMOOTH SHANK
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS.
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 6555642
• Report Number: 0009617544-2017-00196
• Device Sequence Number: 1266901
• Product Code: KWP
• UDI-Device Identifier: 04546540469731
• UDI-Public: (01)04546540469731
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K032394
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/25/2018

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 Model Number: 48556328
• Device Catalogue Number: 48556328
• Device Lot Number: 091832
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/15/2017
• Supplement Date Received by Manufacturer: Not provided; 06/29/2018
• Initial Report FDA Received Date: 05/09/2017
• Supplement Report FDA Received Date: 05/16/2017; 07/25/2018
• 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: 79 YR
• Patient Weight: 98