MAUDE Adverse Event Report: ZIMMER DENTAL XFR HEX DIRECT SCR-V 3.5M M NECK 4.5MM IMP; DENTAL IMPLANT

Model Number DHT3/4

Device Problem Component Missing (2306)

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

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet (b)(4).Patient identifier, age and date of birth.Gender, patient weight unknown / not provided.Date of event unknown / not provided.Pma/510(k) number unknown / not provided.

Event Description

It was reported that clinician indicated implant box was empty, it had only product information inside.No other product available in the dr.Office.Clinician was unable to finish the procedure as the box was empty.

Manufacturer Narrative

This report is being submitted to relay corrected data, additional information and device evaluation.The following sections are being reported: h6: component code was updated/corrected: 4747.H6: type of investigation codes were added: 4109, 4110, 4111, 4114 and 3331.H6: investigation findings code was added: 213.H6: investigation conclusions code was added: 67.The xfr hex direct scr-v 3.5m m neck 4.5mm imp (dht3/4) and packaging were not returned, therefore, visual evaluation of the product could not be performed.The investigation was performed using applicable instructions for use and risk files to address reported event.Dhr review for the lot (2019040794) revealed no deviations nor non-conformances which could have caused or contributed to the reported event.All products were conforming at the time they left zimmer biomet.Lot was inspected and passed all acceptance criteria by qa.The dhr was further reviewed to verify the packaging process.No malfunction or nonconformance was identified.Complaint history review was performed for the reported lot number (2019040794) for similar events (complaint category keyword: packaging: incorrect component quantity, packaging other) and no other complaint was identified.November post market trending was reviewed and there were no actionable events or corrective actions for the reported event or products.Therefore, based on the available information, device malfunction and the reported event could not be verified since the condition of the products/packaging as received by the customer was unknown/non-verifiable.

Event Description

No additional event information at the time of this report.

• Brand Name: XFR HEX DIRECT SCR-V 3.5M M NECK 4.5MM IMP
• 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: 12310063
• MDR Text Key: 266104855
• Report Number: 0002023141-2021-02093
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 00889024014589
• UDI-Public: (01)00889024014589(17)240412(10)2019040794
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DHT3/4
• Device Catalogue Number: DHT3/4
• Device Lot Number: 2019040794
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2019
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Prefer Not To Disclose