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

Catalog Number 1476300500

Device Problems Break (1069); Corroded (1131); Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Date 03/08/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The product is not returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.Submitted product images displays broken rod.X-ray image review: "post op images are provided for long segment thoraco-lumbar fixation.The set screw one side at l5 has come loose.There is a paucity of bone at multiple levels where inter body grafting has been performed.Unable to assess sagittal balance and deformity correction on provided imaging.Root cause: indeterminate.".

Event Description

It was reported that patient underwent th9-s2ai, l2/3, l3/4, l4/5, l5/s1 posterior lumbar interbody fusion using spinal instrumentation.Post-op, rod breakage and corrosion due to metallosis were observed.Revision surgery was performed for fixation because the left side rod broke between l5/s1 and a rod deviated.After surgery at th9-s2ai, fixation was performed at l3-s1 and reinforcement was conducted at the inside of l3-s1 using a rod (it was connected with mrc).The broken rod was removed.It was reinforced using a rod inside the part where rod breakage occurred.

Manufacturer Narrative

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

Manufacturer Narrative

Device evaluation: rod: a section of a rod was returned ~7.4cm long.A microscopic review of the fracture face reveals a sharp step ~ in the middle of the diameter of the rod and signs of crack propagation located adjacent to this sheer lip.The microscopic analysis did not reveal signs of cyclic fatigue in the fracture surface.It would appear that the damage may have been caused by a sudden force being exerted on to the rod.If information is provided in the future, a supplemental report will be issued.

• 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: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6452521
• MDR Text Key: 71460912
• Report Number: 1030489-2017-00727
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1476300500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2017
• Initial Date FDA Received: 04/03/2017
• Supplement Dates Manufacturer Received: 03/08/2017; 04/18/2018
• Supplement Dates FDA Received: 10/02/2017; 04/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: SET SCREWS
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR