MAUDE Adverse Event Report: STRYKER SPINE-US OASYS 3.5X26MM POLYAXIAL SCREW; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	48552326
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Return status of the device is unknown.
Event or Problem Description
Stryker representative reported that during removal surgery, an oasys polyaxial screw head came off from main screw.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Upon visual inspection of the device, the tulip is confirmed to be disengaged from the shank.The bottom surface of the tulip, area connecting tulip and shank, did not reveal any cracks/fractures.The threads of the tulip did not show any abnormality.The shank revealed deformation around the head, likely due to the removal procedure.Device and complaint history records were reviewed, and no relevant manufacturing issues or similar complaints were identified.Per instructions for use: once implanted, the implants are subjected to stresses and strains.These repeated stresses on the implants must be taken into consideration by surgeon at the time of the choice of the implant, during implantation as well as in post-operative follow-up period.Indeed, the stresses and strains on the implants may cause metal fatigue or fracture or deformation of the implants, before the bone graft has become completely consolidated.This may result in further side effects or necessitate the early removal of the osteosynthesis device.Improper selection, placement, positioning and fixation of these devices may result in unusual stress conditions reducing the service life of the implant.As the bottom surface of the tulip did not reveal any cracks/fractures, it is likely that the tulip experienced excessive, instantaneous removal force.As the device was implanted for approximately 4 years, the device could have had existing stress concentrations/patterns as well.It is likely that excessive removal force compounded with pre-existing stress concentrations could have caused the tulip to disengage from the shank upon removal.
Event or Problem Description
Stryker representative reported that during removal surgery, an oasys polyaxial screw head came off from main screw.No adverse consequences or medical intervention were reported.

• Brand Name: OASYS 3.5X26MM POLYAXIAL SCREW
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9759456
• Report Number: 0009617544-2020-00030
• Device Sequence Number: 19011231
• Product Code: NKG
• UDI-Device Identifier: 04546540380524
• UDI-Public: 04546540380524
• Combination Product (Y/N): N
• PMA/510(K) Number: K151755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2020

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: 48552326
• Device Catalogue Number: 48552326
• Device Lot Number: 052101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 05/11/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 06/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1