MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 1476300500

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Product is not marketed in us.510(k) for similar product marketed in us with catalogue # 1474000500 is k091974.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 oct 31, 2011, the second implant was on sep 18, 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.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Type of Device: ORTHOSIS, 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 Key: 10778336
• MDR Text Key: 214350848
• Report Number: 1030489-2020-01569
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• 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: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1476300500
• Device Catalogue Number: 1476300500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 90 YR
• Patient Weight: 38