MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. MEDTRONIC LP CERVICAL TITANIUM DISC; PROSTHESIS, INTERVERTEBRAL DISC

Model Number MEDTRONIC PRESTIGE LP

Device Problems Break (1069); Mechanics Altered (2984); Scratched Material (3020)

Patient Problem Failure of Implant (1924)

Event Date 06/28/2021

Event Type  Injury  

Event Description

Report by patient, (b)(6).On (b)(6) 2021 i underwent surgery at (b)(6) hospital in (b)(6).The hardware and implants for the surgery were provided by the regional supplier for (b)(6).The surgery involved 4 cervical levels from c3-c7 to correct cervical disc disease.A discectomy was performed on each level.Level c3/4 disc was replaced by a medtronic prestige lp artificial titanium disc, serial #(b)(4).Level c4/5 and level c5/6 were both fused with a single plate and associated hardware.Level c6/7 was replaced by a medtronic prestige lp artificial titanium disc, serial #(b)(4).The recovery from this surgery was very difficult, and the majority of the symptoms were only slightly lessened.During a routine x-ray at the three month mark, there appeared to be a misalignment of the c6/7 artificial disc, but i was told at that time that there were no apparent issues with the placement of the implants or with the implants themselves.During the routine 6 month x-ray check up, the image showed what was clearly an issue with the c6/7 medtronic lp disc, and a ct scan was performed.The ct scan clearly showed that the upper half of the artificial disc implanted between the c6/7 was completely broken into two pieces.Surgery was scheduled for the first week of (b)(6) 2022.The faulty medtronic disc was removed by the surgical team, and the c6/7 vertebrae were unfortunately fused as the cervical joint was no longer a good candidate for an artificial disc.Inspection of the broken disc shows that it broke cleanly around the "ball" section of the top half of the medtronic lp disc.No apparent bending of either piece seems evident.The lower half of the disc has scratches on its surface where the broken piece of the upper portion had been rubbing across it during movement of the joint.Fda safety report id# (b)(4).

• Brand Name: MEDTRONIC LP CERVICAL TITANIUM DISC
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC.
• MDR Report Key: 13358777
• MDR Text Key: 284658268
• Report Number: MW5106989
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• 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: 01/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MEDTRONIC PRESTIGE LP
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: MEDTRONIC FUSION HARDWARE; REMAINING MEDTRONIC PRESTIGE LP ARTIFICIAL DISC
• Patient Outcome(s): Required Intervention; Other; Disability; Hospitalization
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White