MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY ANGLED ABUTMENT; DENTAL ABUTMENT

Model Number	8530-52
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A root cause investigation was performed, and allegations reported by the customer were deemed to be false.Part number 8530-51 was not labeled at the same time as part number 8530-52.All manufacturing documents showed that part number 8530-52, lot 135550 was processed correctly.The findings of the investigation support the possibility that the customer having ordered the two parts in question, may have opened the package of part number 8530-52 without breaking the seal and placed the cap for part number 8530-51 on the vial of part number 8530-52.There were no issues identified in the manufacturing process.Review of the job traveler indicated that part number 8530-52 lot 135550 was labeled on 2/20/19.No job for part number 8530-51 was labeled around this date.The closest date for labeling of part number 8530-51 occurred on 04/16/2019.Based on this investigation, it was determined that the product met its specifications upon release and did not malfunction.As a result, the event was classified as not reportable and no further corrective actions were taken.This complaint has since been re-evaluated and is being filed late out of an abundance of caution.
Event or Problem Description
Per complaint (b)(4), it was noticed in the european distribution center that a customer returned product for credit [part 8530-52, lot 13550] had a cap label that did not match the vial label.The cap label returned was for part number 8530-51.

• Brand Name: LEGACY ANGLED ABUTMENT
• Common Device Name: DENTAL ABUTMENT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks, ca
• MDR Report Key: 9975354
• Report Number: 3001617766-2020-02526
• Device Sequence Number: 742192
• Product Code: NHA
• UDI-Device Identifier: 10841307110712
• UDI-Public: 10841307110712
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K090234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 04/17/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/20/2024
• Device Model Number: 8530-52
• Device Catalogue Number: 8530-52
• Device Lot Number: 135550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 04/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1