MAUDE Adverse Event Report: ACE SURGICAL SUPPLY COMPANY INTERNAL HEX IMPLANT; DENTAL IMPLANT

Model Number	204111
Medical Device Problem Codes	Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930); Pain (1994); Numbness (2415)
Date of Event	04/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No evidence was found with the implant itself after evaluation.Customer reported pain, bleeding, numbness, peri-implantitis, infection and inadequate bone quality/bone quantity.
Event or Problem Description
Pain, peri-implantitis, bleeding, infection and inadequate bone quality/bone quantity were reported.Bone quality at the time of implant failure type i.Time of loss in relation to the implantation was 1 to 5 years after prosthetic restoration.Primary stability was achieved.Osseointegration was not achieved.Augmentation procedure was not performed at the time of surgery.

• Brand Name: INTERNAL HEX IMPLANT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ACE SURGICAL SUPPLY COMPANY; 1034 pearl street; brockton MA 02301
• MDR Report Key: 12567710
• Report Number: 1287163-2021-52857
• Device Sequence Number: 17211102
• Product Code: DZE
• UDI-Device Identifier: 00614950004706
• UDI-Public: 00614950004706
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• PMA/510(K) Number: K102981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 204111
• Device Catalogue Number: 204111
• Device Lot Number: 16110087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 10/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR