MAUDE Adverse Event Report: STRYKER SPINE-US OASYS BLOCKER; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	48551000
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Remains implanted.
Event or Problem Description
It was reported that an oasys set screw migrated post-operatively.The surgeon has no plan to revise the patient and will continue to monitor them instead.
Additional Manufacturer Narrative
Visual, dimensional, functional and material analysis could not be performed as the device was not returned.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.A review of complaint history associated with the subject catalog number was performed, and no complaints were identified.Due to lack of information and device not returned, an exact cause of the reported event could not be determined.Per sales rep, "surgeon noted to me verbally today he believes the rods may be too angled at that screw".Potential causes include: rod implanted at an angle, blocker under torqued during initial surgery, unstable construct, etc.
Event or Problem Description
It was reported that an oasys set screw migrated post-operatively.The surgeon has no plan to revise the patient and will continue to monitor them instead.

• Brand Name: OASYS BLOCKER
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11761033
• Report Number: 0009617544-2021-00073
• Device Sequence Number: 3081035
• Product Code: NKG
• UDI-Device Identifier: 04546540371508
• UDI-Public: 04546540371508
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K151755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2021

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: 48551000
• Device Catalogue Number: 48551000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 05/03/2021
• Supplement Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1