MAUDE Adverse Event Report: ZIMMER DENTAL; HEALING ABUTMENT

Device Problem Separation Failure (2547)

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

Event Date 02/04/2021

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet (b)(4).Patient weight unknown / not provided.Brand name unknown / not provided.Lot/serial # unknown / not provided.Device expiration date unknown / not provided.Device udi number unknown / not provided.Pma/510(k) number unknown / not provided.Device manufacturer date unknown / not provided.

Event Description

It was reported that clinician had a tsv4b11 implant and when it was being uncovered at tooth position # 8, healing collar was stuck and while implant came out.Dr.Placed 4.1 x 11.5 but would not take then tried a 4.7 x 11.5 that did take.

Manufacturer Narrative

The imp,tsv,4.1mm,sbm,11.5 (tsv4b11) and unknown zimmer healing abutment were not returned.Since product has not been returned, visual/functional inspection 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 # 8 (universal) and used for approximately 7 months.The reported event could not be recreated due without return of the devices for testing.The customer has not provided additional pictures or x-ray images of the product.Appropriate documentation was reviewed.Dhr review could not be performed, as the lot number associated with the reported product is not available.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product within specifications.A complaint history review could not be performed without relevant item and lot information.Based on the available information, device malfunction could not be verified and the reported event was non-verifiable.The following sections have been updated: b4: date of this report g3: date received by manufacturer g6: checked "follow-up" h2: checked follow-up type h3: changed "yes" to "no" h6: entered evaluation codes h10: added manufacturer narrative h3 other text : device not returned.

Event Description

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

• Type of Device: HEALING ABUTMENT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11484535
• MDR Text Key: 239813342
• Report Number: 0002023141-2021-00629
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR