• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number 54740007550
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Type  Malfunction  
Manufacturer Narrative

Source: 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 states. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from the healthcare professional (hcp) via the manufacturer representative regarding an event. It was reported that the patient underwent an initial l3-5 posterior fusion and l4 vertebra replacement on (b)(6) 2018 for pre-op diagnosis of l5/s1 intervertebral disc hernia. The patient underwent a revision surgery because the pedicle screw on the right side of l5 broke at the base of the screw head. Hcp tried to remove with a pair of pliers, but it could not be removed. At the hcp's discretion, the screw shaft was left in the body and there was partial explantation. The removed head part was discarded at the hospital. The broken l5 right was skipped and fusion for extending to s1 was performed in the reoperation. There was no health damage in the patient. Product will not be returned since the customer refused return, and it was not replaced with a medtronic product.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11341742
MDR Text Key232320251
Report Number1030489-2021-00219
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberSEE 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
Report Date 02/18/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/18/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number54740007550
Device Catalogue Number54740007550
Device LOT NumberH5420801
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 Received01/29/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured03/17/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-