MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CD HORIZON SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	869-011
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.X-ray review: post-op x-rays from thoraco-sacral fusion show a rod fracture at l3-4.By report x-rays are 5 years post surgery.Instrumentation and deformity correction appears adequate.Given the length of time from surgery this is likely a result of non-union.
Event or Problem Description
Pre-op diagnosis: scoliosis procedure used: posterior scoliosis correction it was reported that the patient underwent surgery in which the rod was implanted.Post-op, the rod was found to be broken on (b)(6) 2017.Patient underwent correction surgery where two connectors with one parallel rod were implanted at the level of the broken rod.No patient complications were reported as a result of the event.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 6889498
• Report Number: 1030489-2017-02101
• Device Sequence Number: 116236
• Product Code: KWP
• UDI-Device Identifier: 00721902750991
• UDI-Public: 00721902750991
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K031655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/30/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 869-011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2017
• Initial Report FDA Received Date: 09/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 80