MAUDE Adverse Event Report: ZIMMER DENTAL HEAL COLLAR 3.5X3.5, 5MM; HEALING COLLAR

Model Number N/A

Device Problems Unsealed Device Packaging (1444); Component Missing (2306)

Patient Problem No Information (3190)

Event Date 09/27/2018

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Patient information not provided/unknown.

Event Description

It was reported that the healing collar (hc335) packaging was not sealed and the product was missing.No other abutment was placed.

Manufacturer Narrative

This report is being submitted to relay additional information.The following sections are being reported: it was reported that the healing collar packaging was not sealed and the product was missing.No other abutment was placed.Patient will return for placement.There was no report of patient injury.Date rec¿d by mfr: 25 apr 2019, type of reportable event: serious injury.Device mfr date: 11 jan 2018.The packaging for the reported healing collar was returned for investigation.Visual inspection identified that the package was empty, with only the package insert and a torn portion of paper within the package.The reported condition of "the healing collar packaging was not sealed and the product was missing" could not be verified, as the product condition when received by the customer is unknown.A device history record (dhr) review for the reported lot number was completed.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 were noted as part of the dhr.A complaint history review was performed for the reported device lot number for similar events and no other complaint was identified.A definitive root cause for the reported event could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that the healing collar packaging was not sealed and the product was missing.No other abutment was placed.Patient will return for placement.There was no report of patient injury.

• Brand Name: HEAL COLLAR 3.5X3.5, 5MM
• Type of Device: HEALING COLLAR
• Manufacturer (Section D): ZIMMER DENTAL; 1900 aston avenue; carlsbad CA 92008
• MDR Report Key: 8279111
• MDR Text Key: 134136843
• Report Number: 0002023141-2019-00038
• Device Sequence Number: 1
• Product Code: NHA
• 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: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: HC335
• Device Lot Number: 2017121069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention