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.
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