MAUDE Adverse Event Report: CENTINEL SPINE, LLC. PRODISC L US SUPERIOR ENDPLATE; PROSTHESIS, INTERVERTEBRAL DISC

Model Number UNKNOWN

Device Problem Expulsion (2933)

Patient Problem No Information (3190)

Event Date 03/25/2020

Event Type  Injury  

Manufacturer Narrative

The information provided from the reporter indicates that the pdl inlay has expelled from the inferior endplate.The reason for expulsion is unknown according to the surgeon.The pdl was intended to be removed and replaced; however, patient anatomy prohibited the safe removal of the device.The patient's iliac vein could not be mobilized to allow safe access to the pdl level.The surgeon aborted the procedure, leaving the pdl implant in place.Dhr review was not completed as no device identification was provided.The rate of complaints was found to be within allowable limits per the risk assessment.The associated risks for this complaint were identified and found to be mitigated.No further investigation could be performed as no device or x-ray images were provided from the case.The investigation could not determine a cause for the inlay expulsion.If additional information becomes available regarding this submission, follow up reports will be submitted as appropriate.

Event Description

A patient scheduled for revision surgery due to pe inlay expulsion.No indication of patient symptoms or complications related to the malfunction.Surgical intervention to correct the pe inlay expulsion was attempted, but could not be performed due to the patient's iliac vein adhering to the spinal column in the operative area.The surgeon was unable to mobilize the vein to allow for safe removal of the prodisc l device.The procedure was aborted once this determination was made.No other interventions were performed.

• Brand Name: PRODISC L US SUPERIOR ENDPLATE
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE, LLC.; 900 airport rd, suite 3b; west chester, pa
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester, pa
• Manufacturer Contact: jason smith ; 900 airport rd, suite 3b; west chester, pa ; 8878839
• MDR Report Key: 9973033
• MDR Text Key: 191567826
• Report Number: 3007494564-2020-00019
• 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: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2020
• 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