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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SOLERA VOYAGER SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SOLERA VOYAGER SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number 55750015545
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Internal Organ Perforation (1987); Ulcer (2274)
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 infection of l3-4 involved in spinal therapy. Levels implanted: th11-s. It was reported that during use, backed-out screws contacted skin to form pressure ulcer and perforation. There was patients symptoms/ complications reported as a result of the event. There was no delay in overall procedure time. Patient was not hospitalized prolong as a result of the event. Skin flap formation and plastic was performed by department of plastic surgery to extend the fixation on (b)(6) 2020. It was reported patient issue is resolved. There was health damage on the patient reported due to screw back out. On (b)(6) 2020, received additional information that levels screw backed out was l1-l2. Reported all 4 screws backed out hence in revision surgery screws were removed and returned to patient. Confirmed revision surgery was performed due to backed-out screws contacted skin to form pressure ulcer and perforation. Flap formation was performed by plastic surgery. Revision surgery was performed to extend the fixation on (b)(6) 2020 at levels:th10-l2.
 
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Brand NameCD HORIZON SOLERA VOYAGER SPINAL SYSTEM
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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
tricha miles
1800 pyramid place
memphis, TN 38132
7635140379
MDR Report Key10927063
MDR Text Key218928321
Report Number1030489-2020-01724
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K170679
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number55750015545
Device Catalogue Number55750015545
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/18/2020
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

Patient Treatment Data
Date Received: 12/01/2020 Patient Sequence Number: 1
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