MAUDE Adverse Event Report: BIOHORIZONS IMPLANT SYSTEMS BIOHORIZONS HEXED ABUTMENTS

Model Number PYHYB

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

This report summarizes one (1) malfunction event.A review of the event indicated that the reported abutment demonstrated a misalignment of the hex.The report was received from one source.No patient adverse event was reported.No information regarding the patient demographic was provided.

Manufacturer Narrative

The complaint investigation determined the abutment hex was manufactured slightly off rotation from the manufactured specifications.The nonconforming product was removed from available inventory for additional review and evaluation.The root cause was a manufacturing specification error of the product.

Manufacturer Narrative

There are a total of four (4) malfunction events being reported related to hex alignment with the hybrid abutment.All four complaints had product returned for investigation.The units returned were evaluated product evaluation determined the hex was out of alignment with the base of the abutment.The alignment was not within the manufacturing specifications.Therefore, the product was determined to be nonconforming.The hex was slightly off rotation from its manufacturing drawing.The manufacturing drawing as well as trend data was reviewed as part of the investigation.A review of the manufacturing drawing revealed the drawing to remain correct in its specifications as designed.The trend data review revealed these four occurrences were the only reported complaints for the allegations reported.The investigation concluded that the item was manufactured outside of its intended specifications.A capa was issued to the supplier of the product to correct the issue.No other complaints have sense been reported.Mfr report number 1060818-2021-12024 was previously submitted.However, the mfr report number was overwritten accidently in e*submitter with a single adverse event report.Therefore, the details of mfr report number 1060818-2021-12024 required reentry.The reentry of 1060818-2021-12024 is corrective action being taken for e*submitter and transmission.The details for report number 1060818-2021-12024 were previously submitted no later than (b)(6) 2021.The original report was accidentally overwritten on (b)(6) 2021 when a single mdr event dated (b)(6) 2021 for complaint (b)(4) was processed, keyed, and transmitted.The single mdr event for complaint (b)(4) should have not been assigned 1060818-2021-12024 because 1060818-2021-12024 had already been used and transmitted.Report number 1060818-2021-12024 was originally slated for the 2021 3rd quarter voluntary summary malfunction report associated with a misaligned hex.Mfr report number 1060818-2021-15678 was created to allow for the correction of the single mdr event associated with complaint number (b)(4).Overall, the submission of 1060818-2021-12024 is to correct the reinstate the report ending 12024 that was overwritten in error on (b)(6) 2021.

Event Description

This report summarizes four (4) malfunction events.A review of the events indicated that the reported product demonstrated the external features of the abutment did not align with the hex.The report was received from various sources.No patient adverse events were reported.No information regard the patient demographics were provided.

• Brand Name: BIOHORIZONS HEXED ABUTMENTS
• Type of Device: 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: 12786516
• MDR Text Key: 281507472
• Report Number: 1060818-2021-12024
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Number of Events Reported: 4
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PYHYB
• Device Catalogue Number: PYHYB
• Device Lot Number: 2102616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1