|
Catalog Number UNK XTRAFIX EXTERNAL FIXATION |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
|
Patient Problem
Insufficient Information (4580)
|
Event Type
Injury
|
Event Description
|
It was reported a 12 month pmcf single-centre, retrospective consecutive series study reported an anonymized patient group, from united kingdom, that looked at the safety, performance, and clinical benefits of the xtrafix large and small external fixation systems.The purpose of the study was the assessment of safety and performance, recorded by the ability of the device to stabilize the fracture of long bones during the course of treatment, until the device is exchanged by another device for definite fracture treatment.Case id 10 underwent placement of a xtrafix device, at an unknown site.Subsequently, seven days later, underwent an orif without xtrafix readjustment, for an unknown reason.Attempts have been made and no further information has been provided.
|
|
Manufacturer Narrative
|
(b)(4).Foreign source: event occurred in the united kingdom.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.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.Zimmer biomet will continue to monitor for trends.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Manufacturer Narrative
|
No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause cannot be determined.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
|
Event Description
|
It was further reported by a retrospective study, a patient underwent placement of a xtrafix device, at an unknown site on a right extremity.Subsequently, a ct scan identified loss of position on day seven; therefore, returned for definitive treatment earlier than planned.An orif was completed on day 9 and the event was considered resolved.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h6, h10 a definitive root cause cannot be determined.The reported event is not confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
|
Search Alerts/Recalls
|
|
|