Catalog Number UNK_WWA |
Device Problem
Malposition of Device (2616)
|
Patient Problems
Necrosis (1971); Implant Pain (4561)
|
Event Date 12/14/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.Device not returned.
|
|
Event Description
|
It was reported by the patient that,"your prostep medullary rod toggles in the metatarsal bone shaft, destroying my metatarsal bone.I need bone grafting.The screw that should have been secured in the distal osteotomy segment was in soft tissue causing nonunion and avn.I developed extreme pain and a palpable screw head.The intramedullary implant was loose and toggling as early as post op weeks 1 and 3.The podiatrist would not disclose the problem until i discovered it at week 16.I will have numerous surgeries revisions and bone grafting patient will have a revision on (b)(6)2022 to have a screw removed and have the rod out of metatarsal shaft.".
|
|
Event Description
|
It was reported on mw5109312 by the patient that, "your prostep medullary rod toggles in the metatarsal bone shaft, destroying my metatarsal bone.I need bone grafting.The screw that should have been secured in the distal osteotomy segment was in soft tissue causing nonunion and avn.I developed extreme pain and a palpable screw head.The intramedullary implant was loose and toggling as early as post op weeks 1 and the podiatrist would not disclose the problem until i discovered it at week 16.I will have numerous surgeries revisions and bone grafting patient will have a revision on (b)(6) 2022 to have a screw removed and have the rod out of metatarsal shaft.".
|
|
Manufacturer Narrative
|
The reported event (necrosis) could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Radiographic images provided were post revision.Without images post initial implant and pre revision, no further assessment can be made.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling was not possible because the catalog number and lot number were not communicated.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.
|
|
Search Alerts/Recalls
|