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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Status and location of the device is unknown.
Event or Problem Description
It was reported that a patient received revision surgery to explant 2 oasys blockers and 2 rods which had migrated post-operatively from an occipital plate.This report captures the first of the two blockers.
Event or Problem Description
It was reported that a patient received revision surgery to explant 2 oasys blockers and 2 rods which had migrated post-operatively from an occipital plate.This report captures the first of the two blockers.
Additional Manufacturer Narrative
Visual, functional, dimensional, and material analysis inspections could not be performed as the device was not available.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.Complaint history records were reviewed for this catalog number, no adverse trends were identified.The oasys torque wrench used to final tighten the blockers was returned for functional evaluation.The device was slightly deformed at the distal tip, however, it was functioning as intended and reached the intended 3 nm.It could not be confirmed whether or not the oasys torque wrench contributed to the migration of the blockers.As the explanted blockers were not returned, further evaluation of the capture mechanism could not be conducted.Some possible root causes include: insufficient rod reduction into the tulip seat, blockers under tightened due to misaligning torque indicating arrows on the torque wrench, high post-operative activity, external trauma, etc.

• Brand Name: OASYS BLOCKER
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 12529643
• Report Number: 0009617544-2021-00166
• Device Sequence Number: 12096824
• Product Code: NKG
• UDI-Device Identifier: 04546540371508
• UDI-Public: 04546540371508
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K151755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2022

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: Health Professional
• Device Model Number: 48551000
• Device Catalogue Number: 48551000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2021
• Supplement Date Received by Manufacturer: 12/23/2021
• Initial Report FDA Received Date: 09/24/2021
• Supplement Report FDA Received Date: 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown