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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON® SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON® SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 54840006545
Device Problem Fracture (1260)
Patient Problems Pain (1994); Swelling/ Edema (4577)
Event Date 09/10/2018
Event Type  Injury  
Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The information was received from the consumer via a company representative for solera screw regarding a spinal therapy. It was reported that the solera screw was broken after the surgery. On (b)(6) 2018, the plaintiff had an ls-sl spinal fusion surgery at (b)(6) hospital. This procedure involved the implantation of a rod and screws. The screws are identified as solera non -cannulated mas 6. 5 mm by 40mm and 6. 5 mm by 45mm screws. Initially the patient did well and his back pain was much improved. Thereafter, the patient condition deteriorated and he had an increase in his back pain with pain radiating into his right foot. On (b)(6) 2019, x-rays showed that the pedicle screws in the sacrum had fractured bilaterally. Surgeon concluded that the hardware had failed. As a result, the hoped for fusion at l5-s1 had also failed. Surgeon has recommended another surgery to remove and replace the hardware. During this time the patient condition has continued to worsen. He has had a significant increase in pain. His spine is unstable. Between the time the pedicle screws were implanted and the time the screws fractured and broke, the patient was following all doctor's orders and instructions and had experienced no physical trauma or other event which could have caused the failure. The patient with his diagnosis of lumbar stenosis with neurogenic claudication and corresponding symptoms, was a foreseeable consumer of the subject screws. There was no further complication reported.
 
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Brand NameCD HORIZON® SPINAL SYSTEM
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
MDT SOFAMOR DANEK PUERTO RICO MFG
barrio marianna rd 909, km0.4
humacao PR 00792
Manufacturer (Section G)
MDT SOFAMOR DANEK PUERTO RICO MFG
barrio marianna rd 909, km0.4
humacao PR 00792
Manufacturer Contact
glen belmer
1800 pyramid place
memphis, TN 38132
6122713209
MDR Report Key10882947
MDR Text Key217717140
Report Number1030489-2020-01674
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091974
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number54840006545
Device Catalogue Number54840006545
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/22/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/23/2020 Patient Sequence Number: 1
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