BIOMET MICROFIXATION STERNALOCK BLU SYSTEM SCREW, CANCELLOUS CROSS-DRIVE LOCKING, 2.4 X 18MM; BONE SCREW
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Model Number N/A |
Device Problem
Migration (4003)
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Patient Problem
No Information (3190)
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Event Date 08/08/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: biomet microfixation sternalock 360 multi implant system, catalog #: 74-0004, lot #: 563510, biomet microfixation sternalock blu system screw, cancellous cross-drive locking 2.4 x 16mm, catalog #: 73-2416, lot #: ni.(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2018-00777-1 and 0001032347-2018-00870.
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Event Description
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It was reported there was a revision due to the bands pulling through the sternum.The patient had a coughing fit about a week after the primary operation and the sternalock 360 bands pulled through the sternum.The surgeon removed the implants and revised the patient with a robicsek wiring technique to hold the sternum together.The surgeon advised that this can happen when such a patient with a high bmi coughs a lot.No additional patient consequences were reported.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The reported event was confirmed as a revision was reported.The product was not returned and therefore could not be visually evaluated or functionally tested.It was reported that the patient, who had a bmi of 55, had a coughing fit approximately one week after the primary operation, and the band pulled through the sternum.The instructions for use (ifu) for this product states in the section titled possible adverse effects: 3.Migration, bending, fracture or loosening of the implant.The device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Investigation results concluded that the reported event was due to patient condition.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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Event Description
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This follow-up report is being submitted to relay additional information.
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