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

Catalog Number	641100075
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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.
Event or Problem Description
Procedure: oblique lumbar inter-body fusion (olif), posterior fusion levels implanted: l2-4 it was reported that on an unknown date, one week post-op, the implanted rod dislocated from the l4 screw head.No revision has been scheduled.No complications were reported as a result of the event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 6593334
• Report Number: 1030489-2017-01346
• Device Sequence Number: 10979630
• Product Code: NKB
• UDI-Device Identifier: 00643169501379
• UDI-Public: 00643169501379
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2017

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 Expiration Date: 08/13/2023
• Device Catalogue Number: 641100075
• Device Lot Number: 0409959W
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/02/2017
• Supplement Date Received by Manufacturer: 05/02/2017
• Initial Report FDA Received Date: 05/26/2017
• Supplement Report FDA Received Date: 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR