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

Model Number	4540020
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); Device Embedded In Tissue or Plaque (3165)
Date of Event	11/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr is being filed for notification purpose only.It is unknown which of the three reported screws malfunctioned or contributed to the reported allegation.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
The information received from health care provider via a manufacturing representative regarding a patient with lumbar arthrodesis for spinal fusion therapy.It was reported that the patient complaining of pain 3 month after the surgery, from the x-ray examination it was found that implanted screws was broken.Once the second surgery was scheduled, it was evident that due to the position of the broken screw, it was not possible to completely remove this implant and, therefore, it was not replaced.There was fragment of implant remaining in the patient.There was no further information reported.Patient medical history- smoking use.

• Brand Name: CD HORIZON ESSENCE¿ 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
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 14344076
• Report Number: 1030489-2022-00452
• Device Sequence Number: 20142886
• Product Code: KWP
• UDI-Device Identifier: 00643169428898
• UDI-Public: 00643169428898
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K142591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/10/2022

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 Model Number: 4540020
• Device Catalogue Number: 4540020
• Device Lot Number: H5682829
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 05/10/2022
• Date Device Manufactured: 05/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male