MAUDE Adverse Event Report: STRYKER SPINE CERVICORE INTERVERTEBRAL DISC

Device Problems Metal Shedding Debris (1804); Patient-Device Incompatibility (2682)

Patient Problems Toxicity (2333); Reaction (2414); No Code Available (3191)

Event Date 02/21/2008

Event Type  Injury  

Event Description

On (b)(6) 2008, i was implanted with a rogue cervical metal on metal device called cervicore and manufactured by stryker spine.This implant took place at (b)(6) hospital, (b)(6) and the surgeon is (b)(6).I have severe metal poisoning, tumors and metallosis and early signs of leukemia.The surgeon who implanted this rogue device refuses to follow up or report any of the adverse effects because it will raise red flags that he implanted a device that did not have an ide or any exemption or approval from the fda.

• Brand Name: CERVICORE INTERVERTEBRAL DISC
• Type of Device: CERVICORE INTERVERTEBRAL DISC
• Manufacturer (Section D): STRYKER SPINE
• MDR Report Key: 4867459
• MDR Text Key: 5865050
• Report Number: MW5043209
• Device Sequence Number: 1
• Product Code: MJO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/18/2015

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: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/18/2015
• Patient Sequence Number: 1
• Treatment: VITAMIN D; ALPHA LIPOIC ACID; MULTIVITAMIN
• Patient Outcome(s): Life Threatening
• Patient Age: 58 YR
• Patient Weight: 73