GO DIRECT COLLAR
Received Aug 28, 2020 · Event occurred Jul 9, 2020
Report 3001617766-2020-06246 · MDR key 10468579
Device
Generic name
Dental Collar
Manufacturer
Implant Direct Sybron Manufacturing LlcCatalog number
423713-L
Lot number
161834
Product problems
- Patient Device Interaction Problem
- Patient Device Interaction Problem
Patient
77 YR
- Failure of Implant
- No Consequences Or Impact To Patient
- Failure of Implant
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
FOLLOW-UP SUBMITTED TO REPORT DEVICE EVALUATION. UPDATED SECTION B4 FOR REPORT SUBMISSION DATE AND B6 TO REPORT DEVICE EVALUATION RESULTS. UPDATED D9 FOR DEVICE RETURN DATE, G1 FOR FOLLOW-UP REPORT SUBMITTER, G3 FOR AWARENESS DATE AND G6 FOR REPORT TYPE AND FOLLOW-UP NUMBER. UPDATED H2 FOR FOLLOW-UP TYPE, H3 FOR DEVICE EVALUATION STATUS AND H6 METHOD, RESULT AND CONCLUSION CODES. THIS COMPLAINT IS BEING SUBMITTED LATE DUE TO THE FURLOUGHS THAT RESULTED FROM THE GLOBAL PANDEMIC AND IS CAPTURED WITHIN DEVIATION 1412.
Additional Manufacturer Narrative
PATIENT'S WEIGHT IS UNKNOWN. UDI NUMBER AND K NUMBER DO NOT APPLY TO THIS PRODUCT.
Description of Event or Problem
PER COMPLAINT (B)(4), WRONG IMPLANT WERE PLACED IN THE PATIENT'S MOUTH AND THERE WAS NO STABILITY. PATIENT EXPERIENCED NO INJURIES. A SECOND SURGERY IS NEEDED.
Remedial action
- Inspection