This medwatch is submitted late due to an unexpectedly high volume of complaints from an international distributor on 1-13-20.The fda was made aware of the high volume of complaints by glidewell.Email response received from the fda on 2-5-20.The patient's race and ethnicity were not provided; however, the patient's nationality is listed as (b)(6).The device inforamtion was not provided.The device has not been returned.If/when the device is returned an investigation will be carried out and a supplemental report will be submitted.His is the second of two implant complaints, see manufacturer report for the remaining complaint : 3011649314-2020-00146.
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The device was returned, but did not transfer to the investigator.However, the non-visual device investigation has been completed and the results are as follows: dhr reviewed; the device was returned, but did not transfer to the investigator.However, the non-visual device investigation has been completed and the results are as follows: stock product reviewed results: not able to review the stock product since customer did not provide the driver's lot number.Investigation results: the device was returned, but did not transfer to the investigator.However, the non-visual device investigation has been completed and the results are as follows: it was not possible to measure the reported devices and perform any fit check, nor was it possible to determine if the reported devices met the specification.Root cause: the root cause cannot be explicitly determined.Both implant and driver were not returned for investigation.There was no evidence found to indicate that the reported issue was caused by the driver.It was also unknown if the customer selected the correct type and size of the driver for implant placement.
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