MAUDE Adverse Event Report: BIOHORIZONS IMPLANT SYSTEMS BIOHORIZONS MULTI-UNIT INDIRECT TRANSFER COPING; MULTI-UNIT INDIRECT COPING

Model Number PXMUIC

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Type  malfunction  

Event Description

This report summarizes two malfunction events.A review of the events involved a coping that would not screw 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 two malfunction events reported.The product was not returned for either of the two events.Therefore, no physical evaluation of the product has occurred.Because no product has been returned no conclusion may be drawn impacting the product.Manufacturing/production records were reviewed.No nonconformances were documented within the production records.The conclusion is that the product was manufactured to specification.This report was attempted to submit on (b)(6) 2022.However, due to webtrader system issues, the report would not transmit via webtrader.An esg helpdesk ticket was opened on (b)(6) 2022 covering the issue.The ticket number was (b)(4).Ticket (b)(4) was resolved on (b)(6) 2022.Hence, allowing for the attempt to transmit on (b)(6) 2022.Device: indirect transfer coping, multi-unit.

• Brand Name: BIOHORIZONS MULTI-UNIT INDIRECT TRANSFER COPING
• Type of Device: MULTI-UNIT INDIRECT 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: 14290017
• MDR Text Key: 292577080
• Report Number: 1060818-2022-05031
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Number of Events Reported: 2
• 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
• Device Model Number: PXMUIC
• Device Catalogue Number: PXMUIC
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1