Catalog Number UNK_ENO |
Device Problems
Device Dislodged or Dislocated (2923); Patient Device Interaction Problem (4001)
|
Patient Problems
Bacterial Infection (1735); Swelling/ Edema (4577)
|
Event Date 10/01/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.The catalog number is not known at this time, therefore the gtin could not be determined.However, should it become available it will be provided in future reports.
|
|
Event Description
|
It was reported within a publication by daniel garriguez-perez that the patient had a deep infection with fibrinopurulent reaction with positive cultures for staphylococcus epidermidis and foreign body granulomas in the anatomopathological study.After the removal of this tissue, targeted antibiotic treatment with levofloxacin was initiated, symptoms ceased, and acute phase reactants normalized in blood tests.
|
|
Manufacturer Narrative
|
This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.Alleged failure: poor results after arthroscopic treatment of irreparable rotator cuff tears using a subacromial balloon spacer probable root cause: application: implant used in contraindicated or ill-advised patient population.Manufacture date is not known.H3 other text : 81.
|
|
Event Description
|
It was reported within a publication by daniel garriguez-perez that the patient had a deep infection with fibrinopurulent reaction with positive cultures for staphylococcus epidermidis and foreign body granulomas in the anatomopathological study.After the removal of this tissue, targeted antibiotic treatment with levofloxacin was initiated, symptoms ceased, and acute phase reactants normalized in blood tests.
|
|
Search Alerts/Recalls
|