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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US OASYS BLOCKER; POSTERIOR CERVICAL SCREW SYSTEM
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STRYKER SPINE-US OASYS BLOCKER; POSTERIOR CERVICAL SCREW SYSTEM Back to Search Results
Catalog Number 48551000
Device Problems Unintended Movement (3026); Migration (4003)
Patient Problem Injury (2348)
Event Date 04/24/2019
Event Type  Injury  
Event Description
A revision surgery was performed to replace the blocker which migrated post-operatively.The surgeon noted during the revision surgery that the rod had shifted; therefore, the rod, c3 and c4 screw were replaced, as well as the c3 and c4 blockers.
 
Manufacturer Narrative
Visual analysis found the blocker had appropriate contact marks from being tightened down onto the rod inside the polyaxial screws.Complaint history records were reviewed for the lot number provided and no similar events were identified.Manufacturing history records were reviewed for the lot number provided and no relevant manufacturing issues were identified.It was confirmed that the blocker had backed out via photo images provided.It was reported that the patient has myelopathy, fusion was not achieved, patient did not experience a fall and there were no complications during the surgery.The blockers were tightened to 3nm.The surgical technique states: "for patients with degenerative disease, the progression of degenerative disease may be so advanced at the time of implantation that it may substantially decrease the expected useful life of the appliance.In such cases, orthopaedic devices may be considered only as a delaying technique or to provide temporary relief." the plausible root cause of the reported event is patient disease.
 
Event Description
A revision surgery was performed to replace the blocker which migrated post-operatively.The surgeon noted during the revision surgery that the rod had shifted; therefore, the rod, c3 and c4 screw were replaced, as well as the c3 and c4 blockers.
 
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Brand Name
OASYS BLOCKER
Type of Device
POSTERIOR CERVICAL SCREW SYSTEM
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
MDR Report Key8625899
MDR Text Key145602419
Report Number0009617544-2019-00072
Device Sequence Number1
Product Code NKG
UDI-Device Identifier04546540371508
UDI-Public04546540371508
Combination Product (y/n)N
PMA/PMN Number
K151755
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 07/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number48551000
Device Lot Number2HF
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/24/2019
Date Manufacturer Received06/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age57 YR
Patient Weight64
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