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

Device Problems Output Problem (3005); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

This report summarizes 9 malfunction events.A review of the events involved stripped abutment.The report was received from various sources.No patient adverse events were reported.No information regarding the patient demographics were provided.

Manufacturer Narrative

There was a total of 9 malfunctioned events associated with a stripped abutment.8 of the 9 units were not returned for investigation.Since product was not returned for investigation, no conclusion can be drawn.A review of the device history record did not reveal any noted nonconformance.Hence, the conclusions determined the units were manufactured to specifications.1 of the 9 units were returned damaged by the end user.Failure caused by improper technique or improper use of product.Items involved - abutment screw, multi-unit abutment.

Manufacturer Narrative

There are a total of 9 malfunctioned events with a stripped abutment.8 of the 9 units did not have product returned for evaluation.Since, product was not returned for evaluation no conclusion may be drawn to the cause of the stripped abutments.A review of the device history record did not reveal any noted nonconformances.Hence, the devices were manufactured to specifications.1 of the 9 units were returned for evaluation.It was concluded the evaluation was damaged by the end user.The failure cause was improper technique by the end user.Updated information the original file was sent on 10/29/2021 for 3rd quarter.Additionally, the details for report number 1060818-2021-12030 were previously submitted on 10/29/2021.The original report was accidentally overwritten on 11/10/2021 when a single mdr event dated 10/11/2021 for complaint (b)(4) was processed, keyed, and transmitted.The single mdr event for complaint (b)(4) should have not been assigned 1060818-2021-12030 because 1060818-2021-12030 had already been used and transmitted.Report number 1060818-2021-12030 was originally slated for the 2021 3rd quarter voluntary summary malfunction report covering fractured hex abutments.Mfr report number 1060818-2021-15684 was created to allow for the correction of the single mdr event associated with complaint number (b)(4).Overall, the submission of 1060818-2021-12030 is to correct and reinstate report 1060818-2021-12030 which was overwritten in error on 11/10/2021.

Event Description

This report summarizes 9 malfunction events.A review of the events involved abutments that have stripped.The report was received from various sources.No patient adverse events were reported.No information regarding patient demographics were provided.

Event Description

This report summarizes 9 malfunction events.A review of the events involved abutments that have stripped.The report was received from various sources.No patient adverse events were reported.No information regarding patient demographics were provided.

Manufacturer Narrative

There are a total of 9 malfunctioned events with a stripped abutment.8 of the 9 units did not have product returned for evaluation.Since, product was not returned for evaluation no conclusion may be drawn to the cause of the stripped abutments.A review of the device history record did not reveal any noted nonconformances.Hence, the devices were manufactured to specifications.1 of the 9 units were returned for evaluation.It was concluded the evaluation was damaged by the end user.The failure cause was improper technique by the end user.Updated information the original file was sent on 10/29/2021 for 3rd quarter.Additionally, the details for report number 1060818-2021-12030 were previously submitted on 10/29/2021.The original report was accidentally overwritten on 11/10/2021 when a single mdr event dated 10/11/2021 for complaint (b)(4) was processed, keyed, and transmitted.The single mdr event for complaint (b)(4) should have not been assigned 1060818-2021-12030 because 1060818-2021-12030 had already been used and transmitted.Report number 1060818-2021-12030 was originally slated for the 2021 3rd quarter voluntary summary malfunction report covering fractured hex abutments.Mfr report number 1060818-2021-15684 was created to allow for the correction of the single mdr event associated with complaint number (b)(4).Overall, the submission of 1060818-2021-12030 is to correct and reinstate report 1060818-2021-12030 which was overwritten in error on 11/10/2021.

• Brand Name: BIOHORIZONS ABUTMENT
• Type of Device: CUSTOM CAST - 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: 12786519
• MDR Text Key: 281510148
• Report Number: 1060818-2021-12030
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Number of Events Reported: 9
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,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
• 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; Not provided
• Supplement Dates FDA Received: 05/19/2022; 09/15/2022
• 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