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

Model Number 55740005530

Device Problem Malposition of Device (2616)

Patient Problems Rupture (2208); Numbness (2415)

Event Date 09/02/2020

Event Type  Injury  

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 Description

Information was received from healthcare professional via manufacturer representative regarding patient with symptoms of tumor involved in posterior fusion procedure used in spinal therapy.Levels implanted- t8 3a3b.It was reported post-op, product at ps medial side ruptured.As a result, patient symptoms-numbness in the lower limbs was reported.Also, bone ruptured in the patient was reported.There was no delay in the surgery.Patient was not hospitalized for prolong.Patient outcome- health damage in the patient was reported.Reported date of planned explant: (b)(6) 2020 received updated information that screw was penetrated into the medial spinal canal.The direction of the screw was shifted, and the trajectory of the screw has passed inside the pedicle.It was reported due to the their technical error the screw was penetrated into the medial spinal canal or deviated.There is no malfunction reported with the screw.Reported patient had recovered from the problem.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Type of Device: 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: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 10593917
• MDR Text Key: 208798681
• Report Number: 1030489-2020-01350
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K202328
• 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: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 55740005530
• Device Catalogue Number: 55740005530
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2020
• 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