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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 54740006545
Device Problem Break (1069)
Patient Problems Pain (1994); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Event Date 11/06/2020
Event Type  malfunction  
Manufacturer Narrative
This part is not approved for use in the united states; however a like device catalog # 54840006545, 510k #k091974 and udi #: (b)(4) was cleared in the united state. Radiographic image result - post-op x-ray for l4-s1 posterior spinal interpretation. Pedicle screw at l4 to s1 are seen, an interbody graft is present at l4-s1. There appears to be screw loose present in the interbody space. Both of the s1 screws appear fractured. 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 l5 spondylolytic spondylolisthesis involved in l4-s(l5/s:plif) procedure used in spinal therapy. Levels implanted - l4 to s1ps. It was reported that during use, the screws of ps on both sides of s1 broke. The delay in overall procedure was less than 60 minutes. Additional surgery was performed to remove the broken screw. Revision surgery was performed to remove broken screw as patient felt back pain. It was reported they tried to remove the broken screw with pse1, but the removing was given up because the spinal canal was near and it would defeat the purpose if the nerve root is damaged. Device status reason : explanted-partial initial surgery - plif was performed at l5/s due to l5 spondylolytic spondylolisthesis. Ps was used at l4 since the pedicle of l5 was thin due to l5 pedicle aplasia and ps was difficult. On 2020-nov-17, received additional information that product that was collected after revision surgery will be returned. There was no pain reported after the re-operation.
 
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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 Key10910440
MDR Text Key221291602
Report Number1030489-2020-01700
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
SEE H10
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,Followup
Report Date 05/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number54740006545
Device Catalogue Number54740006545
Device Lot NumberH5461598
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/24/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/09/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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