MAUDE Adverse Event Report: BIOHORIZONS IMPLANT SYSTEMS BIOHORIZONS IMPRESSION COPING

Model Number ODSIC

Device Problem Connection Problem (2900)

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

Event Type  malfunction  

Event Description

This report provides a summary of one (1) malfunction event.A review of the event involved the product having an engagement issue.No patient adverse event was reported.No information regarding patient demographics have been provided.

Manufacturer Narrative

There was one malfunction event reported with the abutment having an engagement/snapping issue.Product was returned for investigation.An examination of the product revealed no deformation or damage was observed.A review of the device history record did not note any non-conformances.So, the conclusion was determined to have been manufactured to specification.The returned product passed ivt test.Therefore, the product functioned as designed.A conclusion may be drawn that the connection was a usage issue in the field.(b)(4).

• Brand Name: BIOHORIZONS IMPRESSION COPING
• Type of Device: IMPRESSION 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: 15136490
• MDR Text Key: 297050205
• Report Number: 1060818-2022-09396
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ODSIC
• Device Catalogue Number: ODSIC
• Is the Reporter a Health Professional?: Yes
• 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