InterActive® Precision IO Scan Adapter 6534-09PTRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10841307123477), received between Oct 24, 2018 and Feb 22, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 22, 2019Material Integrity Problem; Material Integrity Problem

  PER COMPLAINT (B)(4), DURING UNPACKING, THE SCAN ADAPTER BODY WAS IN TWO PARTS. THE PLASTIC CAME OFF THE BASE.

  Patient problems: No Patient Involvement

  MAUDE report 8363638 ↗
• MalfunctionNov 1, 2018Component Misassembled; Component Misassembled

  PER COMPLAINT (B)(4), THE PEEK PART OF THE MULTI-USE SCAN ADAPTOR WAS LOOSE ON THE TITANIUM BASE.

  Patient problems: No Patient Involvement

  MAUDE report 8031219 ↗
• MalfunctionOct 24, 2018Component Misassembled; Component Misassembled

  PER COMPLAINT (B)(4), THE PEEK PART OF THE MULTI-USE SCAN ADAPTOR WAS LOOSE ON THE TITANIUM BASE.

  Patient problems: No Patient Involvement

  MAUDE report 8003168 ↗
• MalfunctionOct 24, 2018Component Misassembled; Component Misassembled

  PER COMPLAINT (B)(4), DURING THE REMOVAL OF THE PEEK-TITANIUM SCAN ADAPTER FOR THE DENTAL IMPLANT, THE PEEK PART WAS LOOSE ON THE TITANIUM BASE. THE SCAN ADAPTOR WAS COMPROMISED AND A NEW APPOINTMENT WAS SCHEDULED FOR THE PATIENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8001429 ↗