MAUDE Adverse Event Report: ZIMMER DENTAL HEAL COLLAR 3.5X4.5, 5MM; DENTAL ABUTMENT

Model Number HC345

Device Problem Misassembled (1398)

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

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).

Event Description

Doctor reports that it was unable to screw the healing collar during the implant placement.He has finished the procedure placing another healing collar and the implant is fine.

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).The following fields have been updated: b4: date of this report.B5: describe event or problem.G3: date received by manufacturer.G6: type of report.H1: type of reportable event.H2: follow up type.H3: device evaluated by manufacturer.H6: adverse event problem.H10: additional narrative.One heal collar 3.5x4.5, 5mm (hc345) was returned for investigation.Visual evaluation of the as returned products identified some signs of use and but no apparent malfunction identified.Device history record (dhr) review was completed for the subject lot number 2020070836.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 by lot number (2020070836) was performed for similar events and no other similar complaint was identified.Therefore, based on the available information, device malfunction did not occur and the reported event was unconfirmed.

Event Description

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

• Brand Name: HEAL COLLAR 3.5X4.5, 5MM
• Type of Device: DENTAL ABUTMENT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11527188
• MDR Text Key: 241056096
• Report Number: 0002023141-2021-00695
• Device Sequence Number: 1
• Product Code: NHA
• UDI-Device Identifier: 00889024015005
• UDI-Public: (01)00889024015005(17)250721(10)2020070836
• Combination Product (y/n): N
• PMA/PMN Number: K111852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HC345
• Device Catalogue Number: HC345
• Device Lot Number: 2020070836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR