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

Catalog Number	1604200500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that patient with adult degenerative disease and scoliosis underwent spinal surgery from t10 - pelvis.Post-op rod breakage at l5-s1 was observed causing pain to the patient.It is not confirmed whether surgeon will perform revision surgery on the patient.
Additional Manufacturer Narrative
Image review: post op x-rays from long segment thoraco lumbar fusion reported.T10-ilium show unilateral rod break at l5-s1 happened before 6 months post op,so we assume fusion has not occurred.Pre op long x-rays and post op imaging is not available to assess degree of deformity correction.Root cause :indeterminate.
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 6607197
• Report Number: 1030489-2017-01431
• Device Sequence Number: 16353314
• Product Code: NKB
• UDI-Device Identifier: 00613994990693
• UDI-Public: 00613994990693
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K113174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/13/2017

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: 1604200500
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/09/2017
• Supplement Date Received by Manufacturer: Not provided; 06/13/2017
• Initial Report FDA Received Date: 06/02/2017
• Supplement Report FDA Received Date: 06/23/2017; 10/04/2017
• 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: Other
• Patient Age: 69 YR