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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

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MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON® SPINAL SYSTEM Back to Search Results
Model Number MSB_UNK_VOY_IMP
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Spinal Column Injury (2081)
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
Information was received from healthcare professional via field representative regarding patient with set screw back out involved in the spine re-fixation procedure. Levels implanted: l1-s2. It was reported that post-operatively, the set screw of the s2ai screw backed out. Product was used correctly according to the directions given in the ifu/labeling. Event was revision surgery. There was delay in overall procedure time for over 60 minutes. Initial surgery details- simultaneous anterior-posterior fusion was performed in the operation performed on (b)(6) 2019, and fixation was extended on (b)(6) 2021. Set screw back out occurred, so refixation was performed. On (b)(6) 2022, received additional information that patient symptoms are unknown. On (b)(6) 2022, received updated information that after the initial surgery ((b)(6) 2019), the patient suffered an adjacent segment disease, leading to re-surgery. Clydesdale ptc / voyager 4. 75 was used at the time of the initial surgery, but voyager 4. 75 was removed and replaced with voyager 5. 5 / 6. 0 at the time of re-surgery on (b)(6) 2021. There was a feeling of cross-threading when inserting the set screw of the re-surgery. On (b)(6) 2022, received additional information that levels implanted in the initial surgery- l1-l5.
 
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Brand NameCD HORIZON® SPINAL 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 Key13677978
MDR Text Key286663891
Report Number1030489-2022-00212
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 03/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMSB_UNK_VOY_IMP
Device Catalogue NumberMSB_UNK_VOY_IMP
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/08/2022
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: 03/07/2022 Patient Sequence Number: 1
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