ARTELON SPACER (SMALL BONE INNOVATIONS)

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-04-18 for ARTELON SPACER (SMALL BONE INNOVATIONS) manufactured by Artimplant.

Event Text Entries

[4547493] Artelon implant for cmc joint arthritis. Re contacted dr and re visited (b)(6) 2008. Complained again (b)(6) 2008. Continuing cmc joint pain and dysfunction - was supposed to recover in 6-8 weeks. Prolonged inflammatory response. Artelon cmc arthroscopic spacer insertion (b)(6) 2007 post-op course seemed normal, splinted and then after 6 weeks, started physical therapy (completed). Joint didn't seem to settle down, hot with burning pain. Return to dr for recheck. He said all was well. Had another course of physical therapy without improvement fall of 2009. Also a bone scan (total body) showed right thumb "hot" or inflamed. Total body scan 2 years later showed inflammation. I went to another hand surgeon, he said he could do the "gold standard" cmc surgery on the hand to take the spacer out and use my harvested tendon. I never did it, as i was too afraid. I'd already had poor use of my right hand for over 1 year and chronic pain. I contacted the manufacturer regarding inflammatory response problems. They denied it. I contacted the surgeon to see if any of his pts had artelon problems. He denied it. I was on an artelon arthritis blog, and many people were having the same problems as i experienced. In fact, many had gone to lawyers in frustration. The company in (b)(4) went out of business (b)(4) 2013, but was bought by a us company and reopened in (b)(4) 2014. So, these artelon problems will continue. (b)(4). I was told it would be absorbed by my body in 5 years. Wikipedia says, 5-7 years. Company closed ((b)(4)) and reopened (b)(4) due to lawsuits from pts.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5035724
MDR Report Key3763535
Date Received2014-04-18
Date of Report2014-04-19
Date of Event2007-10-11
Date Added to Maude2014-04-24
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameARTELON SPACER (SMALL BONE INNOVATIONS)
Generic NameARTELON SPACER (SMALL BONE INNOVATIONS)
Product CodeKYI
Date Received2014-04-18
OperatorHEALTH PROFESSIONAL
Device Sequence No1
Device Event Key0
ManufacturerARTIMPLANT


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2014-04-18

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