MAUDE Adverse Event Report: STRYKER SPINE-US OASYS 3.5 X 24MM PA SCREW MEDIAL; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number	48555324
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/07/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a screw was implanted on (b)(6) 2017.On (b)(6) 2018, when the screw was removed, during explanation at right of the fourth cervical vertebra, the doctor found that the tulip head and screw thread were separated.Only the screw thread was left in the bone.The bone was scarped and the screw was removed with pliers.There was a 50 minute surgical delay.There were no reports of adverse health consequences to the patient.
Additional Manufacturer Narrative
Method: device history review, complaint history review; risk assessment.Result: the screw tulip was confirmed separated during removal.The purpose of this surgery was to remove the implants as the patient had fused.Manufacturing records for this product were reviewed and no anomalies were found.As per the surgical technique guide "these implants are temporary internal fixation devices designed to stabilize the operative site during the normal healing process.After healing occurs, these devices serve no functional purpose and can be removed." and "removal of an unloosened spinal screw may require the use of special instruments to disrupt the interface at the implant surface." conclusion: the likely cause is the removal of unloosened screw and fusion of the bone to the screw.
Event or Problem Description
It was reported that a screw was implanted on (b)(6) 2017.On (b)(6) 2018, when the screw was removed, during explanation at right of the fourth cervical vertebra, the doctor found that the tulip head and screw thread were separated.Only the screw thread was left in the bone.The bone was scarped and the screw was removed with pliers.There was a 50 minute surgical delay.There were no reports of adverse health consequences to the patient.

• Brand Name: OASYS 3.5 X 24MM PA SCREW MEDIAL
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7314879
• Report Number: 0009617544-2018-00060
• Device Sequence Number: 19161798
• Product Code: NKG
• UDI-Device Identifier: 04546540469557
• UDI-Public: (01)04546540469557
• Combination Product (Y/N): N
• PMA/510(K) Number: K151755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2018

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: Health Professional
• Device Model Number: 48555324
• Device Catalogue Number: 48555324
• Device Lot Number: 164134
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/07/2018
• Supplement Date Received by Manufacturer: 07/09/2018
• Initial Report FDA Received Date: 03/05/2018
• Supplement Report FDA Received Date: 07/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1