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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US 6.5X50 POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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STRYKER SPINE-US 6.5X50 POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number 482616550
Device Problems Material Protrusion/Extrusion (2979); Unintended Movement (3026)
Patient Problems Pain (1994); Injury (2348)
Event Date 01/15/2019
Event Type  Injury  
Event Description
It was reported that the patient was presented with a leg pain post-operatively.A post-op x-ray showed a compromised structure and potential dislodgement of the cage.Further communication with sales rep and ct scan review confirmed that the cage had not been dislodged.An x-ray showed the screw has protruded through the vertebral body into disc space.A revision surgery was performed to remove screw and construct extension from l3-s1.
 
Event Description
It was reported that the patient was presented with a leg pain post-operatively.A post-op x-ray showed a compromised structure and potential dislodgement of the cage.Further communication with sales rep and ct scan review confirmed that the cage had not been dislodged.An x-ray showed the screw has protruded through the vertebral body into disc space.A revision surgery was performed to remove screw and construct extension from l3-s1.
 
Manufacturer Narrative
Visual, dimensional, functional inspection, and material analysis could not be performed as the device was discarded by the hospital.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 reported that the bony anatomy was fractured/deformed and a ¿compromised structure,¿ which included vertebral bodies and pedicles, were confirmed via x-ray.Additionally, the screws protruded through the vertebral body at l4 into the disc space above.A definitive root cause could not be determined, but the patient's poor bone quality, due to osteoporosis, most likely contributed to the screw migration.Osteoporosis is listed as a contraindication in the ifu."poor bone quality can affect the structure integrity and possibly cause the screws to pullout or migrate as the screw purchase may not be as strong as in healthy bone." from the ifu: ¿the surgeon must warn the patient of the surgical risks and make aware of possible adverse effects.The surgeon must warn the patient that the devices cannot and do not replicate the flexibility, strength, reliability or durability of normal healthy bone, that the implants can break or become damaged as a result of strenuous activity or trauma, and that the devices may need to be replaced in the future.If the patient is involved in an occupation or activity which applies inordinate stress upon the implant (e.G., substantial walking, running, lifting, or muscle strain) the surgeon must advise the patient that resultant forces can cause failure of the devices.Patients who smoke have been shown to have an increased incidence of non-unions.Surgeons must advise patients of this fact and warn of the potential consequences.For diseased 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.¿.
 
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Brand Name
6.5X50 POLYAXIAL SCREW
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
MDR Report Key8467486
MDR Text Key140428882
Report Number3005525032-2019-00032
Device Sequence Number1
Product Code NKB
UDI-Device Identifier07613327351552
UDI-Public07613327351552
Combination Product (y/n)N
PMA/PMN Number
K170496
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 06/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number482616550
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received06/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age69 YR
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