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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

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MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON SPINAL SYSTEM Back to Search Results
Model Number MSB_UNK_SSRW_LG
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Necrosis (1971)
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. Medical safety assesses the reported event of ¿necrosis¿ and its reported severity as labeled (per ifu manual number (b)(4) rev. H). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider via a manufacturer representative regarding a patient with spinal therapy. It was reported that the patient had necrosis.
 
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Brand NameCD HORIZON SPINAL 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 Key13657683
MDR Text Key286494905
Report Number1030489-2022-00204
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMSB_UNK_SSRW_LG
Device Catalogue NumberMSB_UNK_SSRW_LG
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/18/2022
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: 03/03/2022 Patient Sequence Number: 1
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