Device product code-dzl."patients with.Insufficient quantity or quality of bone, " is listed in the contraindications in the package insert.The warnings in the package insert state this type of event can occur.The product was discarded by the hospital and therefore will not be returned for an evaluation.Because the lot number is unknown, the device history records could not be pulled and reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.This is report 3 of 4 for the same event.Reports 1, 2, and 4 are reported on mfr # 0001032347-2016-00295, 0001032347-2016-00296, 0001032347-2016-00298.
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The product identity was confirmed through the picture provided by the distributor.The lot numbers of the parts could not be identified.A list of the potential lots where found.The product was not returned.It was discarded as biohazard by the hospital.It was reported that between two and three weeks after the original operation the upper maxillary bar pulled through her maxilla and the screws lost purchase.Customer mentions in one of the correspondences that, "the forces exerted to close down her open bite with bilateral condylar fractures caused the screws to literally cerclage through the maxilla." the intended meaning of this statement is unclear, however, this may be suggesting that the event occurred while attempting to bind the bone fragments together.Customer stated, "this lady's mandible - because of her other comorbidities and dental disease - was mush and her sinuses were low (or conversely her maxilla was thin)." the customer also stated, "screws did not loosen from the plate and we did have the flexibility to find some bony landing points." the customer suggests that the cause of the bars dislocation is due to the patients condition and there was no malfunction of the device.They also provide statements that suggests that the part functioned as intended (screws did not loosen from plate and found fixated in bone fragments) and it was the poor condition of the patient's maxilla.For these reasons, the complaint is considered unconfirmed.The most likely underlying cause of the complaint is patient condition.There are no indications of manufacturing defects.This is report 3 of 4 for the same event.Reports 1, 2, and 4 are reported on mfr # 0001032347-2016-00295-1, 0001032347-2016-00296-1, 0001032347-2016-00298-1.
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