MAUDE Adverse Event Report: ACE SURGICAL SUPPLY CO., INC. INTERNAL HEX; INTERNAL HEX IMPLANT

Model Number	203708
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/13/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Bone quality was not identified.Time of loss in relation to the implantation was before prosthetic restoration.Primary stability was achieved at the time of surgery but implant did not integrate with bone at restoration.Osseointegration augmentation procedure was not performed at the time of surgery.

• Brand Name: INTERNAL HEX
• Common Device Name: INTERNAL HEX IMPLANT
• Manufacturer (Section D): ACE SURGICAL SUPPLY CO., INC.; 1034 pearl street; brockton MA 02301
• MDR Report Key: 11913475
• Report Number: 1287163-2021-00849
• Device Sequence Number: 11558091
• Product Code: DZE
• UDI-Device Identifier: 00614950004621
• UDI-Public: 00614950004621
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K102981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 06/01/2021

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: 203708
• Device Catalogue Number: 203708
• Device Lot Number: 18090089
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 06/01/2021
• 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: 70 YR