Catalog Number SN2027-0-20055 |
Device Problems
Break (1069); Loosening of Implant Not Related to Bone-Ingrowth (4002)
|
Patient Problem
No Code Available (3191)
|
Event Date 12/14/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
Udi number: ni.Without a product return, no product evaluation is able to be conducted.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.Reference report 3003853072-2019-00002.
|
|
Event Description
|
It was reported that a revision surgery was performed to address post-operative loosening of the construct.During the revision, the nylon band broke.This is report one of two for this event.
|
|
Manufacturer Narrative
|
Udi number: (b)(4).Additional information: expiration date and udi number, and method, results, and conclusions codes.The device was not returned, but a photo of the device provided by the reporter was used for evaluation.The band was found to have broken.The cause is likely attributed to unintentional use error.A review of the dhr did not identify any issues which would have contributed to this event.The labeling was reviewed and found to contain instructions regarding proper device usage.
|
|
Event Description
|
It was reported that a revision surgery was performed to address post-operative loosening of the construct.During the revision, the nylon band broke.This is report one of two for this event.
|
|
Manufacturer Narrative
|
Method and results.Visual inspection revealed that, as reported, the band is broken.The u-clamp device was not returned, however, it can be seen from the provided x-rays that it has loosened from its intended position.The cause can likely be attributed to unintentional use error.A review of the dhr did not identify any issues which would have contributed to this event.The labeling was reviewed and found to contain instructions regarding proper device usage.
|
|
Event Description
|
It was reported that a revision surgery was performed to address post-operative loosening of the construct.During the revision, the nylon band broke.This is report one of two for this event.
|
|
Search Alerts/Recalls
|