MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 54740005540

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/27/2020

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k): device is not marketed in us.510(k) no.For similar device with product id as (b)(4) marketed in us is k143375.Device discarded by consumer so evaluation is not possible.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider via a manufacturer representative regarding a patient with pre-operative diagnosis of lumbar spinal canal stenosis.It was a revision surgery in which fusion surgery is done for the patient who had been performed cbt-plif at l3/4, it was planned to extend to l5.Initial surgery is done on (b)(6) 2020.Revision surgery is planned as vertebral fracture on l3 occurred after fixation on l3/4.Additional surgery is planned as a result of this event.The re-operation was performed on (b)(6) 2020 for product explantation.The cause of l3 fracture was caused by the cutout on the right side of the cbt screw at the time of the initial surgery,there was no abnormality like malfunction on the implant itself.The situation was that the screw was not working in the cutout part.The screw was removed in the re-operation, ha stick was added, the screw was inserted.The removed implant was discarded by the medical institution, and was unable to be collected.It was considered to be the user error or patient factors.About the detail, the operating doctor felt that the cutout cbt screw on the right side of l3 was directed too much toward the cranial side.Also, fracture at the cbt puncture site might occur.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• 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: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 10419031
• MDR Text Key: 203341487
• Report Number: 1030489-2020-01088
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/18/2020

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
• Device Operator: Health Professional
• Device Model Number: 54740005540
• Device Catalogue Number: 54740005540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2020
• Initial Date FDA Received: 08/18/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention