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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number MSB_UNK_SOL5.5/6.0
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem Spinal Column Injury (2081)
Event Type  Injury  
Manufacturer Narrative
Report source. Country: (b)(6). 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
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having th11-l5 psf, olif and tlif. The patient's medical history is dialysis, nephrotic syndrome, cushing's syndrome, and ht. It was reported that the patient presented top adjacent intervertebral disorders and the additional surgery was performed for the extension to about th4 using a connector on (b)(6) 2022.  according to the physician, the information is only the extension to about max th4 due to the adjacent intervertebral disorder of the patient underwent initial olif in the first or second case. The four screws on th12 and l1 had been loose and were four out of the fixation from th12 to s1. The four screws were replaced and the screws were returned to the patient. The revision surgery was performed successfully and hook on th4, ps insertion on th5-th11,ps replacement on th12 and l1 and the rods from th4 to l1 and from l2 to s1 were connected by striker's angle connectors. The bone graft was performed with gr strips 20 cm and completed. The type of the procedure was postoperative fixation extension of kyphosis. There were no further complications reported regarding the event.
 
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Brand NameCD HORIZON SPINAL SYSTEM
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
Manufacturer (Section G)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
Manufacturer Contact
glen belmer
1800 pyramid place
memphis, TN 38132
6122713209
MDR Report Key14390407
MDR Text Key291611765
Report Number1030489-2022-00462
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMSB_UNK_SOL5.5/6.0
Device Catalogue NumberMSB_UNK_SOL5.5/6.0
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/15/2022
Was Device Evaluated by Manufacturer? No Answer Provided
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: 05/13/2022 Patient Sequence Number: 1
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