MAUDE Adverse Event Report: CENTINEL SPINE, LLC. PRODISC L TOTAL DISC REPLACEMENT; PROTHESIS, INTERVERTEBRAL DISC

Model Number SSX534K

Device Problems Unintended Movement (3026); Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Blood or Lymphatic problem (4434); Metal Related Pathology (4530); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/02/2020

Event Type  Injury  

Manufacturer Narrative

The patient was under the care of a surgeon for elevated blood serum levels of cobalt and chromium.The blood levels were identified at an unknown date by the patient's total hip arthroplasty surgeon.At the time of this test result, the treating spine surgeon determined that surgical intervention was not necessary.The patient x-rays did show evidence of possible impingement conditions due to scoliosis which developed after the prodisc l devices were implanted.This patient had a 3-level prodisc l construct as part of the prodisc l ide study.The patient was instructed to get additional blood tests to determine the stability of the blood serum levels.At the time the initial spine surgeon felt the patient was doing well and the implants did not need to be removed.The patient went to another spine surgeon at a different clinic in relation to the blood serum levels.The second surgeon determined the patient should have the 3-level pdl implants removed and replaced with unknown devices.There is no indication if additional blood serum tests were conducted or why the second surgeon determined that explantation was appropriate.The explanted device was retrieved and is under evaluation with exponent laboratory as requested by the fda.The investigation found the rate of complaints to be within expected limits based on the risk assessment.The device fmea indicates the associated risks are identified and mitigated as far as reasonably practicable.

Event Description

A patient experiencing elevated blood serum levels of cobalt and chromium underwent a surgical procedure to have a 3-level prodisc l construct removed and replaced with unknown devices.The patient developed scoliosis after implantation resulting in an impingement condition indicated through x-ray images provided during the investigation.

• Brand Name: PRODISC L TOTAL DISC REPLACEMENT
• Type of Device: PROTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE, LLC.; 900 airport rd, suite 3b; west chester PA 19380
• Manufacturer Contact: jason smith ; 900 airport rd, suite 3b; west chester, PA 19380 ; 4848878839
• MDR Report Key: 10587035
• MDR Text Key: 208554530
• Report Number: 3007494564-2020-00036
• 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: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SSX534K
• Device Catalogue Number: N/A
• Device Lot Number: 51254991
• Date Manufacturer Received: 08/27/2020
• 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
• Patient Age: 57 YR