MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TSV,4.1,11.5,MTX,MG; DENTAL IMPLANT

Model Number TSVT4B11

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 03/23/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Patient sex unknown / not provided.Weight unknown / not provided.

Event Description

It was reported that the internal threads of the implant are slightly stripped at tooth location #26 and this was discovered during a clinical procedure of uncovering implants to place the healing collar.Healing collar will not thread onto the implant.Need thread tap.Patient will return to tap and place healing collar.

Event Description

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

Manufacturer Narrative

One implant ,tsv,4.1,11.5,mtx,mg (tsvt4b11) was not returned.Since product has not been returned, visual/functional evaluation could not be performed.The investigation has been performed based on the available information.No pre-existing conditions were noted on the per.The reported product was located on tooth # 26 (universal).The implant was used for approximately 5 months prior to the event date but remains implanted.The reported event could not be recreated due to the nature of the dental device and event (damaged).The customer has not provided additional pictures or x-ray images of the product.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number.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 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: IMP,TSV,4.1,11.5,MTX,MG
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9954469
• MDR Text Key: 187875576
• Report Number: 0002023141-2020-00757
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 00889024019836
• UDI-Public: (01)00889024019836(17)240707(10)1230077(241)TSVT4B11
• Combination Product (y/n): N
• PMA/PMN Number: K101977
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/09/2020

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
• Device Operator: Health Professional
• Device Model Number: TSVT4B11
• Device Catalogue Number: TSVT4B11
• Device Lot Number: 1230077
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/23/2020
• Initial Date FDA Received: 04/13/2020
• Supplement Dates Manufacturer Received: 06/08/2020
• Supplement Dates FDA Received: 06/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR