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

Model Number	404010
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fistula (1862); Failure of Implant (1924); Swelling (2091); Numbness (2415)
Date of Event	01/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event has been determined to be a post-placement/pre-load failure.This implant loss suggests that the source of the problem was likely to stem from procedural errors and/or the lack of osseointegration.Additionally, other factors that may have contributed to the implant failure includes bone condition, patient oral hygiene, or patient behavior.Proper intended use of the implant is described in its instructions for use.Physical analysis cannot be performed.
Event or Problem Description
Bleeding, swelling, numbness and fistula were reported.Bone quality at the time of implant failure type ii.Time of loss in relation to the implantation was before prosthetic restoration.Primary stability and osseointegration was achieved.Augmentation procedure was not performed at the time of surgery.

• Brand Name: EXTERNAL HEX IMPLANT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ACE SURGICAL SUPPLY COMPANY; 1034 pearl street; brockton MA 02301
• MDR Report Key: 8431389
• Report Number: 1287163-2019-51967
• Device Sequence Number: 19098368
• Product Code: DZE
• UDI-Device Identifier: 00614950005468
• UDI-Public: 00614950005468
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K954513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 02/25/2019

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: 404010
• Device Catalogue Number: 404010
• Device Lot Number: 18040031
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 03/19/2019
• 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: 62 YR