MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	7543645
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
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 r eported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent transforaminal lumbar interbody fusion at l4-l5 due to degenerative disc disease and spon dylolisthesis at l4-l5.During 11th month post-op, the patient almost had a fall and felt pain.An x-ray was performed which revealed a broken screw.No fusion was achieved as well.She felt the sudden jolt at her back when she almost fell forward.She was also instructed to avoid these things such as vibration or sudden jolt or flexion and extension movements.No revision surgery has been performed yet.
Additional Manufacturer Narrative
X-ray review results: post-op x-rays of l4-l5 fusion shows a screw fracture at l5.An interbody graft is present.There is a paucity of bone in the interbody space indicating fusion has likely not occurred.By report, this happened after a fall.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 8536991
• Report Number: 1030489-2019-00459
• Device Sequence Number: 1730815
• Product Code: KWP
• UDI-Device Identifier: 00721902857539
• UDI-Public: 00721902857539
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: K031655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2019

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: 7543645
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 04/22/2019
• Supplement Report FDA Received Date: 05/26/2019
• 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: 59 YR