MAUDE Adverse Event Report: INTRA-LOCK INTRA-LOCK ABUTMENT

Model Number ABUTMENT

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

This report summarizes one (1) malfunction event.A review of the event indicated that the reported abutment demonstrated a spinning abutment.The report was received from one source.No patient adverse event was reported.No information regarding the patient demographic was provided.

Event Description

This report summarizes 1 malfunction event.A review of the event involved a stripped abutment.No patient adverse events were reported.No information regarding patient demographics were provided.

Manufacturer Narrative

There are a total of 1 malfunctioned events with a stripped abutment.No product was returned for evaluation.Since, product was not returned for evaluation no conclusion may be drawn to the cause of the stripped abutment.A review of the device history record did not reveal any noted non-conformances.Hence, the devices were manufactured to specifications.Updated information the original file was sent on 10/29/2021 for 3rd quarter.

• Brand Name: INTRA-LOCK ABUTMENT
• Type of Device: INTRA-LOCK ABUTMENT
• Manufacturer (Section D): INTRA-LOCK; 2300 riverchase center; hoover AL 35244
• Manufacturer (Section G): INTRA-LOCK; 2300 riverchase center; hoover AL 35244
• Manufacturer Contact: anissa smith ; 2300 riverchase center; birmingham, AL 35244
• MDR Report Key: 12786517
• MDR Text Key: 281517975
• Report Number: 3003631996-2021-00334
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ABUTMENT
• Device Catalogue Number: ABUTMENT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/10/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1