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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 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number MSB_UNK_LONGITUDE
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Neurological Deficit/Dysfunction (1982); Pain (1994); Numbness (2415)
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 manufacturer representative regarding patient with radicular symptom of l5 involved in posterior lumbar interbody fusion (plif) procedure on l5-s1 used in spinal therapy. It was reported during use, four screws on l2, s1, il were loose and lower limb symptoms occurred on l5. All the screws were removed, ps were added on l1-s1-il, plif was performed on l5-s. Revision surgery was performed on (b)(6) 2019. On (b)(6) 2018, pf was performed on l2-s1 and plif was performed on l4-5. On (b)(6) 2019, additional fixation was performed with two screws on each left and right of il. There was no delay in overall procedure time. Levels implanted: l1-s1-il. Reported additional treatment and patient hospitalization or prolongation of existing hospitalization was necessary to perform plif additionally on l5-s1. Received updated information that patient developed neurological symptoms after the re-surgery on (b)(6) 2020. Screws that were explanted was discarded by the hospital. Health damage in the patient was reported.

 
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Brand NameCD HORIZON 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 Key10581284
MDR Text Key208407063
Report Number1030489-2020-01341
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberUNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/16/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/24/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMSB_UNK_LONGITUDE
Device Catalogue NumberMSB_UNK_LONGITUDE
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/25/2021
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: 09/24/2020 Patient Sequence Number: 1
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