MAUDE Adverse Event Report: BIOHORIZONS IMPLANT SYSTEMS BIOHORIZONS MULTI-UNIT ABUTMENT

Device Problems Mechanical Problem (1384); Connection Problem (2900)

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

Event Type  malfunction  

Manufacturer Narrative

There were two malfunction events reported with the abutment having a short screw and only three threads to engage device.Product was returned for investigation.An examination of the product revealed no deformation or damage was observed.The returned product was not the product designed to use with its interconnecting device.Therefore, the incorrect screw may have been used.Using the incorrect screw will result in connection/engagement issues.(b)(4).

Event Description

This report provides a summary of two (2) malfunction events.A review of the events involved the product having an short abutment screw with three threads engaging.No patient adverse event was reported.No information regarding patient demographics have been provided.

Event Description

This report provides a summary of two (2) malfunction events.A review of the events involved the product having an short abutment screw with three threads enaging.No patient adverse event was reported.No information regarding patient demographics have been provided.

Manufacturer Narrative

There were two malfunction events reported with the abutment having a short screw and only three threads to engage device.Product was returned for investigation.An examination of the product revealed no deformation or damage was observed.The returned product was not the product designed to use with its interconnecting device.Therefore, the incorrect screw may have been used.Using the incorrect screw will result in connection/engagement issues.Health effect- impact code (h6): the health impact associated with the reported problem is rarely provided during the collection of information for the reported malfunction.Therefore, code 4648 is being used in h6 - health effect - impact code.Component code (h6): code 4756 within the component code section of h6 is being used because no other code within annex g is compatible with pro codes nha or ndp.Follow up #1 the model number and catalog number are the same.The udi number is listed in parentheses.Pgmu303 (qty 2) ((b)(4)).

• Brand Name: BIOHORIZONS MULTI-UNIT ABUTMENT
• Type of Device: MULTI-UNIT ABUTMENT
• 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: 15136377
• MDR Text Key: 297149284
• Report Number: 1060818-2022-09400
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Number of Events Reported: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• 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
• 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