MAUDE Adverse Event Report: NOBEL BIOCARE AB GÖTEBORG HEALING ABUTMENT BMK SYST RP Ø4X5MM

Catalog Number	33446
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During the procedure, when the customer wanted to open the package, they realized that the package was sealed with transparent tape and inside there was a different size healing abutment, which was evidently used, due to the stains.
Event or Problem Description
During the procedure, when the customer wanted to open the package, they realized that the package was sealed with transparent tape and inside there was a different size healing abutment, which was evidently used, due to the stains.An investigation has been performed and a capa was initiated.The investigation confirmed this adverse event did not result in any harm.Results of the risk assessment rated 3 for severity, occurrence as 2 and detectability as 4, concluding in a risk priority number of 24.Mitigating actions are required only when the risk priority number exceeds 25 and no control mechanisms are in place.However, considering the potential impact on customers, the decision was made to implement corrective actions regardless.The investigation determined that the incident occurred due to a process deviation during the handling of returned products.The sterile barrier was compromised with a used product found inside.No field actions were deemed necessary.There are no other materials impacted and the scope of the adverse event is condensed to this single item.A capa was initiated and has been closed successfully.
Additional Manufacturer Narrative
An investigation has been performed and a capa was initiated.The investigation confirmed this adverse event did not result in any harm.Results of the risk assessment rated 3 for severity, occurrence as 2 and detectability as 4, concluding in a risk priority number of 24.Mitigating actions are required only when the risk priority number exceeds 25 and no control mechanisms are in place.However, considering the potential impact on customers, the decision was made to implement corrective actions regardless.The investigation determined that the incident occurred due to a process deviation during the handling of returned products.The sterile barrier was compromised with a used product found inside.No field actions were deemed necessary.There are no other materials impacted and the scope of the adverse event is condensed to this single item.A capa was initiated and has been closed successfully.

• Brand Name: HEALING ABUTMENT BMK SYST RP Ø4X5MM
• Common Device Name: ABUTMENT
• Manufacturer (Section D): NOBEL BIOCARE AB GÖTEBORG; bohusgatan 15; göteborg 41139 ; SW 41139
• Manufacturer (Section G): NOBEL BIOCARE AB GÖTEBORG; bohusgatan 15; göteborg 41139 ; SW 41139
• Manufacturer Contact: gayco meel ; popeweg 72; venlo 5928 -SC ; NL 5928 SC ; 623202508
• MDR Report Key: 21439440
• Report Number: 9611993-2025-049560
• Device Sequence Number: 4512618
• Product Code: DZE
• UDI-Device Identifier: 07332747189902
• UDI-Public: (01)07332747189902(10)12256610(17)271101
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K925779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 33446
• Device Lot Number: 12256610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown