MAUDE Adverse Event Report: CUSTOM AUTOMATED PROSTHETICS KEYSTONE; TITANIUM ABUTMENT BLANK

Model Number TI LOBE CONNECTION 5.0/5.5/6.5

Device Problem Detachment Of Device Component (1104)

Patient Problem Difficulty Chewing (2670)

Event Date 05/15/2017

Event Type  malfunction  

Manufacturer Narrative

Oem preform abutment blank customized by cap and sent to dental lab customer for additional processing.Finished abutment sent from dental lab to clinical setting for patient fitment by dentist.After approximately 8 months in situ, it is believed the retaining screw loosened and became disengaged, allowing the abutment-prosthetic to disattach and come loose from the implant.Patient returned to dentist, and had hand-carried the detached abutment-prosthetic for evaluation and replacement.There was no damage to the abutment and it was fit for reinstallation to patient.The original retaining screw was present, undamaged, and indicates it must have backed out of the implant, allowing the abutment to become free.Dentist used a new screw and refit the abutment-prosthetic to the patient.There was no injury associated with the event.

Event Description

Patient returned to dentist office, presented dental implant abutment in their hand.It had disengaged from the implant and was no longer attached.

• Brand Name: KEYSTONE
• Type of Device: TITANIUM ABUTMENT BLANK
• Manufacturer (Section D): CUSTOM AUTOMATED PROSTHETICS; 85 maple street; stoneham MA 02180
• Manufacturer (Section G): CUSTOM AUTOMATED PROSTHETICS; 85 maple street; stoneham MA 02180
• Manufacturer Contact: mark simmons ; 85 maple street; stoneham, MA 02180 ; 8779777889
• MDR Report Key: 6597378
• MDR Text Key: 76154812
• Report Number: 3008741955-2017-00002
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072241
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: TI LOBE CONNECTION 5.0/5.5/6.5
• Device Catalogue Number: 001-0789-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 79