Model Number N/A |
Device Problem
Bent (1059)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/04/2016 |
Event Type
Injury
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Manufacturer Narrative
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Product returned and lot numbers confirmed.The device evaluation is anticipated, a follow up report will be sent upon completion of the product evaluation.Report three of four for the same event, previously reported: 3004485144-2016-00095 and 00096.See also 3004485144-2016-00121.
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Event Description
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The sales associate reported screws that were damaged during surgery.The doctor was performing a lateral fusion procedure with telluride system.The set screw was bent as there was difficulty coming down on the rod, and the pedicle screw end tip was bent.
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Manufacturer Narrative
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The returned device was visually inspected in which it was seen that there was significant thread damage exhibited by the tulip head, however, the tip was not found to be bent as reported.The screw was then functionally tested by attempting to mate a set screw with the tulip head but the set screw could not engage.The complaint is confirmed.The dhr shows that there were no nonconformances or manufacturing issues noted that may have contributed to the event.The reporting rep noted that the patient in the procedure had hard bone meaning this likely contributed to the damages that occurred with the implants.It is also likely that the set screw was misaligned upon insertion, leading to the thread deformation that is seen.
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Search Alerts/Recalls
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