MAUDE Adverse Event Report: SYNTHES BRANDYWINE PRODISC L TOTAL DISC REPLACEMENT; PROSTHESIS, INTERVERTEBRAL DISC

Model Number PRODISC L SUPERIOR ENDPLATE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271); Inadequate Pain Relief (2388)

Event Date 11/01/2019

Event Type  Injury  

Manufacturer Narrative

Information provided for this case indicates the patient anatomy (blood vessels and scar tissue) prevented the removal of the prodisc l device from being completed successfully.The patient was experiencing continued pain, but there was no direct link established to indicate this pain was caused or contributed to by the device.Communications suggested this prodisc l device may not have been the best treatment for the patient.There was no alleged malfunction of the prodisc l device indicated.The device was left implanted within the patient, and a posterior fusion is expected to occur at a later date.Patient specific information was not provided.A date for the posterior fusion is unknown and not provided to centinel spine.The risks associated with this adverse event are known and fully mitigated per the device risk assessment.No trends in previous complaints for this device were identified.

Event Description

Prodisc l removal was scheduled for a patient due to continued pain.While attempting to access the level of implantation for the pdl, the access surgeon could not mobilize the blood vessels which were anterior to the pdl device.There was significant scar tissue anterior to the device as well.Due to the blood vessel obstruction, the surgical team determined removal of the pdl was too high a risk.The procedure was aborted, and the patient's surgical wound was closed without further issues.The reported information indicates the patient would receive a posterior fusion to limit the motion of the prodisc l device at a later date.

• Brand Name: PRODISC L TOTAL DISC REPLACEMENT
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: jason smith ; 900 airport rd, suite 3b; west chester, PA 19380 ; 4848878839
• MDR Report Key: 9377638
• MDR Text Key: 185485689
• Report Number: 3007494564-2019-00022
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/25/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: PRODISC L SUPERIOR ENDPLATE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/30/2019
• Initial Date FDA Received: 11/26/2019
• 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