Catalog Number 3003940001 |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/20/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Foreign report source: (b)(6).The device was not returned to the manufacturer.Therefore it could not be analyzed.The review of the device manufacturing quality record indicate that 3231 products désignation refobacin bone cement r 40 ref.3003940001, batch a749dc0513 were manufactured on (17th may 2018).The device manufacturing quality record (of6306390) indicates that the released product met all requirements to perform as intended.No non conformity or deviation was observed which could be linked to the complaint issue (complaint category innercement pouch open sealing) event described in the complaint.The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.
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Event Description
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It was reported that inner sterile packaging was found to be opened during the surgery.No adverse event has been reported as a result of the malfunction.This event involves three products.
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Event Description
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It was reported that inner sterile packaging was found to be opened during the surgery.No adverse event has been reported as a result of the malfunction.This event involves three products.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.The device was not returned to the manufacturer.Therefore it could not be analyzed.However, some photos have been recorded and can confirmed the reported event.The review of the device manufacturing quality record indicate that 3231 products désignation refobacin bone cement r 40 reference 3003940001, batch a749dc0513 were manufactured on (17th may 2018).The device manufacturing quality record (of 6306390) indicates that the released product met all requirements to perform as intended.No non conformity or deviation was observed which could be linked to the complaint issue (complaint category inner cement pouch open sealing) event described in the complaint.22 complaints have been recorded over the batch a749dc0513 within one year.According to available data, the most probable root cause is due to packaging issue (sealing process).Corrective action has been initiated to address reported issue.A customer letter has been sent to the customer to inform the issue.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.
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Search Alerts/Recalls
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