MAUDE Adverse Event Report: MEDTRONIC RECOMBINANT BONE MORPHOGENETIC PROTEIN (INFUSE)

Catalog Number 7510400

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 07/01/2013

Event Type  Injury  

Event Description

Had 2 medtronic (b)(4) rods placed in lower back in (b)(6) 2012.Both rods broke in (b)(6) 2013 necessitating more surgery in (b)(6) 2013.Replacement was with 4 medtronic (b)(4) rods.In (b)(6) 2012, because of stenosis and scoliosis, i had implantation of two (b)(4) rods to the lower back.They both broke on the same day in (b)(6) 2013.There was a loud pop and no outward indication of what had happened.Upon a visit to the physician, the xray showed the rods both broken.It didn't appear as if full fusion had occurred, but the physician would have to validate that.The removal of the broken rods and the replacement of the new 4 (b)(4) rods was done in (b)(6) 2013.After much research and seeing the internet chat rooms where people complained about "broken rods," my wife contacted medtronic.She was told that they do not track the product because of patient privacy.I believe there are many ways to track (by hospital, physician, etc), but it was evident that they did not want to hear from us.My wife also contacted the hospital where the surgery was done.Quality management personnel told her that they had no reports of broken rods from the previous 6 years.Because we had appointments with consulting surgeons who told us they occasionally deal with broken rods, we found it hard to believe that the reports are not being made.It appears that ensuing surgeries are labeled revisions, so i don't know that the codes make it easy to pick up on the fact that rods are broken.I have complete copies of my medical record from both hospitalizations and procedures.I believe that there is a disconnect in this being reported by physicians and hospitals.I have the letters that i have written to the hospital.I also expect to go and obtain the rods as they have been in legal lock up at the hospital since they were removed.It appeared that the lawyers we contacted did not want to tangle with the manufacturer and we did not desire to sue the physician.More surgery to remove broken rods and have replacement.

• Brand Name: RECOMBINANT BONE MORPHOGENETIC PROTEIN (INFUSE)
• Type of Device: RECOMBINANT BONE MORPHOGENETIC PROTEIN (INFUSE)
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 3695534
• MDR Text Key: 4252590
• Report Number: MW5035109
• Device Sequence Number: 3
• Product Code: NEK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 7510400
• Device Lot Number: M111110AAR
• Patient Sequence Number: 1
• Treatment: ATORVASTATIN; IMPLANTED; 4 (B)(4) RODS MADE BY MEDTRONICS,; DIOVAN; ASA; TOPROL; NEXIUM
• Patient Outcome(s): Hospitalization
• Patient Age: 74 YR