• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WARSAW ORTHOPEDICS 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
 

WARSAW ORTHOPEDICS CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number 1476100500
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Product is not marketed in us. 510(k) for similar product with catalogue # 1476200500 is k132111. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider via a manufacturer representative regarding a patient with pre-operative diagnosis of pressure ulcer formation on the skin and metal allergy. It was a revision surgery. It was reported that there was rod breakage. Subcutaneous pressure ulcer was formed, it was unknown whether it was caused by rod breakage. Additional surgery of removing all performed as a result of this event. No health damage in the patient was reported. There were no fragment of the implant remained in the patient. The first implant was on (b)(6) 2011, the second implant was on (b)(6) 2012. The original main complaint, vertebral body fracture, was cured and the pain was relieved, and there was no worsening of symptoms due to rod breakage. The pressure ulcer that had formed around the crosslink that had entered the thoracic was partially excised and sutured, and the fractured part was not the cause of the pressure ulcer because the treatment was performed at a distance from the fractured part according to the operating surgeon opinion. Bedsore was reported around where x10 crosslink was placed.
 
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)
WARSAW ORTHOPEDICS
2500 silveus crossing
warsaw IN 46582
Manufacturer (Section G)
WARSAW ORTHOPEDICS
2500 silveus crossing
warsaw IN 46582
Manufacturer Contact
tricha miles
1800 pyramid place
memphis, TN 38132
7635140379
MDR Report Key10917067
MDR Text Key218698981
Report Number1030489-2020-01707
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
Report Date 11/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/21/2022
Device Model Number1476100500
Device Catalogue Number1476100500
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 Received11/07/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/04/2014
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: 11/30/2020 Patient Sequence Number: 1
-
-