MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM; DENTAL IMPLANT

Model Number TSVB10

Device Problem Packaging Problem (3007)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Patient identifier unknown / not provided.Age and date of birth unknown / not provided.Patient sex unknown / not provided.Weight unknown / not provided.Date of the event unknown / not provided.Email address was not provided.Premarket identification pma/510(k) number k011028 and k013227.Product not returned.

Event Description

Doctor reported that inside the inner box there was no implant.The procedure was completed using another implant.

Event Description

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

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).

Event Description

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

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).A impl tapered scr-v sbm 3.7mm 3.5mm 10mm (tsvb10) was not returned, however, the packaging was returned to zb eu authorized representative.Since product has not been returned to pbg, visual/functional inspection could not be performed.The investigation has been performed based on the available information and attached image.According to the image and eu investigation, no implant was visible/found inside the inner box.Seal can be seen broken.Device history record (dhr) review was completed for the subject lot number (1221079).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 was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (1221079) for similar event and no other complaint was identified.Based on the available information, device malfunction could not be verified and the reported event was non-verifiable.

• Brand Name: IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10769551
• MDR Text Key: 214137837
• Report Number: 0002023141-2020-01854
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 00889024019508
• UDI-Public: (01)00889024019508(17)231010(10)1221079(241)TSVB10
• Combination Product (y/n): N
• PMA/PMN Number: K061410
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2023
• Device Model Number: TSVB10
• Device Catalogue Number: TSVB10
• Device Lot Number: 1221079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1