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

Model Number 303511

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Failure of Implant (1924)

Event Date 06/27/2018

Event Type  Injury  

Manufacturer Narrative

This implant loss suggests that the source of the problem was likely to stem from procedural errors.Correct use and procedural instructions are described in this product's instructions for use.

Event Description

Incorrect size was reported.Time of loss in relation to the implantation was before prosthetic restoration.Bone quality at the time of implant failure was type iv.Primary stability was achieved.Augmentation procedure was not performed.Patient has diabetes mellitus.

• Brand Name: TRICAM INTERNAL IMPLANT
• Type of Device: 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: 7717615
• MDR Text Key: 114936170
• Report Number: 1287163-2018-00484
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 00614950005185
• UDI-Public: 00614950005185
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103790
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 07/19/2018

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
• Device Operator: Health Professional
• Device Model Number: 303511
• Device Catalogue Number: 303511
• Device Lot Number: 18020036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2018
• Initial Date FDA Received: 07/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR