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

Catalog Number	641100040
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Pre-operative diagnosis- lumbar foraminal stenosis with disc disorder procedure- posterior lumbar interbody fusion(plif) levels implanted- l5/s it was reported that the rod was inserted with percutaneous pedicle screw technique, but the postoperative x-ray image showed that the rod which was on the right cranial side came off from the screw and revision surgery was performed immediately.There was a delay of less than a 60 minutes as a result of this event.No patient complications were reported during this event.

• Brand Name: CD HORIZON SOLERA 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: 8513541
• Report Number: 1030489-2019-00420
• Device Sequence Number: 1576180
• Product Code: NKB
• UDI-Device Identifier: 00643169501447
• UDI-Public: 00643169501447
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 641100040
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 04/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR