MAUDE Adverse Event Report: BIOHORIZONS IMPLANT SYSTEMS BIOHORIZONS COPING; IMPLANT COPING

Device Problem Fitting Problem (2183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

This report summarizes three (3) malfunction events.A review of the events involved a coping that would fit into corresponding implant accessories.The report was received from various sources.No patient adverse events were reported.No information regarding patient demographics was provided.

Manufacturer Narrative

There were three (3) malfunction events reported.All three of the events had product returned for evaluation.From the product evaluation, it has been determined that two (2) of the reported units functioned as designed.The third (3rd) unit was determined to be misused by the end-user.Evaluations with known lot numbers had their manufacturing and production documents reviewed.No non-conformances were noted within the production documents.No manufacturing defects were noted during the evaluation of the returned product.Therefore, the conclusion was the devices were manufactured to specifications.From the product evaluation, it has been determined that one (1) of the reported devices was misused by the end-user.The production/manufacturing documents were reviewed.No non-conformances were noted.Therefore, the conclusion was the product was manufactured to specifications.The returned unit had observed deformation from usage.The deformation was due to improper technique or improper usage of the product.Because the device was used improperly, this contributed to the coping not fitting the implant as required.Devices involved: 3.0mm direct pickup coping, long, hexed.Internal 3.5mm regular direct pick-up coping, hexed.(b)(4).

• Brand Name: BIOHORIZONS COPING
• Type of Device: IMPLANT COPING
• Manufacturer (Section D): BIOHORIZONS IMPLANT SYSTEMS; 2300 riverchase center; birmingham AL 35244
• Manufacturer (Section G): BIOHORIZONS IMPLANT SYSTEMS; 2300 riverchase center; birmingham AL 35244
• Manufacturer Contact: anissa smith ; 2300 riverchase center; birmingham, AL 35244
• MDR Report Key: 14289910
• MDR Text Key: 293349095
• Report Number: 1060818-2022-05032
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Number of Events Reported: 3
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1