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

Model Number	204113
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Swelling/ Edema (4577)
Date of Event	07/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual evaluation of product under 65x magnification showed no signs of physical defects.Mount is still attached and is totally damaged.
Event or Problem Description
Bone quality at the time of implant failure type i.Time of loss in relation to the implantation was before prosthetic restoration.Primary stability was achieved.Osseointegration was achieved.Augmentation procedure was not performed at the time of surgery.Patient developed an infection.Mobility and pain were also reported.

• Brand Name: INTERNAL HEX
• Common Device Name: DENTAL IMPLANTS
• Manufacturer (Section D): ACE SURGICAL SUPPLY; 1034 pearl street; brockton MA 02301
• Manufacturer (Section G): ACE SURGICAL SUPPLY; 1034 pearl street; brockton MA 02301
• Manufacturer Contact: bryanna derocha ; 1034 pearl st; brockton, MA 02301 ; 8004413100
• MDR Report Key: 13059860
• Report Number: 1287163-2021-02915
• Device Sequence Number: 1426959
• Product Code: DZE
• UDI-Device Identifier: 00614950004713
• UDI-Public: 00614950004713
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 12/20/2021

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: 204113
• Device Catalogue Number: 204113
• Device Lot Number: 19720011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Unknown