MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION SUPERION INDIRECT DECOMPRESSION SYSTEM; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE

Model Number 101-9808

Device Problem Migration (4003)

Patient Problem Vertebral Fracture (4520)

Event Date 01/25/2022

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event.Product family superion implant: upn 101-9810, model 101-9810, lot 700089, batch 700089.

Event Description

It was reported that the patients pain returned.The physician wanted to explant the patients superion indirect decompression spacer so that he could implant a competitors device.It was noted that the spacer had migrated.During the explant procedure, the physician noticed the spinous process of lumbar 4 was fractured, and he was unable to place the competitors device.The physician determined that the lumbar 4-5 implant should also be removed since the status of lumbar 4s sp was unknown.Both implants were removed successfully.There is no further treatment plan for this patient.The patient was doing fine post-operatively.The superion indirect decompression spacer and the competitors spacer were retained by the facility and therefore will not be returned.

• Brand Name: SUPERION INDIRECT DECOMPRESSION SYSTEM
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): VERTIFLEX INC; carlsbad CA 92010
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 13451120
• MDR Text Key: 285045666
• Report Number: 3006630150-2022-00359
• Device Sequence Number: 1
• Product Code: NQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101-9808
• Device Catalogue Number: 101-9808
• Device Lot Number: 800276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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