|
Model Number CONV DEFIANCE FP |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Damage to Ligament(s) (1952)
|
Event Date 02/17/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
No device was returned for evaluation.If the device is received, a follow-up report will be submitted upon completion of product evaluation.
|
|
Event Description
|
It was reported that the patient was "practicing with her school team while wearing her brace, [patient] planted her left leg and turned to shoot and went down screaming.She did not hear a pop this time but the pain was worse then the first time.[sic] [patient] saw an orthopedist the day after her injury, (b)(6) 2020.They did an x-ray at that time which didn't show anything.They followed up with an mri [magnetic resonance imaging] on thursday (b)(6) 2020.The following monday we saw the same orthopedic surgeon that preformed the first surgery and he confirmed the results of the mri showed a re-tear of the acl [anterior cruciate ligament] in her left knee and it was decided she needed another surgery.Her new surgery is scheduled for (b)(6) 2020." no further information is currently available.
|
|
Manufacturer Narrative
|
G1,2: updated manufacturer point of contact information.H3, h6: device was returned for product evaluation.During this evalution the device was found to be both in good condition and functional.Per the condition, functionality, and manufacturing forms - the device was found to be built within device specifications and no issues were identified.
|
|
Search Alerts/Recalls
|
|
|