MAUDE Adverse Event Report: ACE SURGICAL SUPPLY TRI-CAM INTERNAL IMPLANT

Model Number	305008
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930); Swelling/ Edema (4577)
Date of Event	09/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual evaluation of product under 65x magnification showed no signs of physical defects.
Event or Problem Description
Bruxism, swelling and infection were reported.The bone quality at the time of implantation was type i.Primary stability and osseointegration were not achieved.

• Brand Name: TRI-CAM INTERNAL IMPLANT
• Common Device Name: TRI-CAM INTERNAL IMPLANT
• Manufacturer (Section D): ACE SURGICAL SUPPLY; 1034 pearl st; brockton MA 02301
• Manufacturer (Section G): ACE SURGICAL SUPPLY; 1034 pearl st; brockton MA 02301
• Manufacturer Contact: bryanna derocha ; 1034 pearl st; brockton, MA 02301 ; 8004413100
• MDR Report Key: 12984667
• Report Number: 1287163-2021-00959
• Device Sequence Number: 17461578
• Product Code: DZE
• UDI-Device Identifier: 00614950005260
• UDI-Public: 00614950005260
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K103790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 11/11/2021

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 Expiration Date: 10/30/2025
• Device Model Number: 305008
• Device Catalogue Number: 305008
• Device Lot Number: 20110008
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2021
• Initial Report FDA Received Date: 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (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: 48 YR
• Patient Sex: Unknown