MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TAPERED SP 3.7MM 12M M OCTAGON; DENTAL IMPLANT

Model Number SPB12

Device Problem Packaging Problem (3007)

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

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).

Event Description

Distributor reported that in the past ,they had a few implants with the inner seal broken.He was able to complete the operation very easily.

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).The following fields have been updated: g4: premarket identification k011245 and k002188.

Event Description

No further event information is available at the time of the report.

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Six (6) impl tapered sp 3.7mm 12m m octagon (spb12) were not returned for investigation.Visual inspection could not be performed.The investigation has been performed based on the available information using the item and lot number along with the applicable device history record (dhr), instructions for use (ifu), and risk file.The coob could not be verified, as the original product packaging was not returned.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.Pre-existing patient factors, x-ray, tooth location are not relevant to the reported event.Device history record (dhr) review was completed for the subject lot number (2019112009).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Sterilization record (op0511) was reviewed and verified to have passed all sterilization activities with no issues or nonconformities identified.Complaint history review was performed for the reported lot number (2019112009) for similar events and no other complaint was identified.Review completed utilizing keywords: damaged or un-sealed sterile barrier.Based on the available information, device malfunction could not be verified and the reported event was non-verifiable with the information provided.Additionally, the coob could not be verified, as the original product packaging was not returned.

Event Description

No further event information is available at the time of this report.

• Brand Name: IMPL TAPERED SP 3.7MM 12M M OCTAGON
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 15251363
• MDR Text Key: 302704104
• Report Number: 0002023141-2022-02099
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 00889024017184
• UDI-Public: (01)00889024017184(17)241202(10)2019112009
• Combination Product (y/n): N
• Reporter Country Code: LE
• PMA/PMN Number: K082639
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SPB12
• Device Catalogue Number: SPB12
• Device Lot Number: 2019112009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1