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

Model Number	214708
Medical Device Problem Codes	Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Mobility and inadequate bone quality/bone quality were reported.Bone quality at the time of implant failure type iii.Time of loss in relation to the implantation was before prosthetic restoration.Primary stability was achieved.Osseointegration was not achieved.Augmentation procedure was not performed at the time of surgery.
Additional Manufacturer Narrative
No evidence was found with the implant itself after evaluation.Customer reported the implant was mobile and loss of integration.

• Brand Name: INTERNAL HEX IMPLANT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ACE SURGICAL SUPPLY COMPANY; 1034 pearl street; brockton MA 02301
• Manufacturer (Section G): ACE SURGICAL SUPPLY COMPANY; 1034 pearl street; brockton MA 02301
• Manufacturer Contact: doreen price ; 1034 pearl street; brockton, MA 02301 ; 8004413100
• MDR Report Key: 13232494
• Report Number: 1287163-2022-00971
• Device Sequence Number: 11832384
• Product Code: DZE
• UDI-Device Identifier: 00614950007172
• UDI-Public: 00614950007172
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 01/10/2022

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: 214708
• Device Catalogue Number: 214708
• Device Lot Number: 21070041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 01/11/2022
• 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: 56 YR
• Patient Sex: Female