Model Number 7116-0512-N |
Device Problem
Break (1069)
|
Patient Problem
Device Embedded In Tissue or Plaque (3165)
|
Event Date 01/04/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
Outcomes attributed to adverse event: other : revision surgery scheduled.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient for dlif spinal therapy at l2-5.It was reported that broken cage remains in patient. there was fragment of the implant or instrument remaining in the patient. there was no patient symptom reported.There were no further complications reported regarding the event.Additional information received states that revision surgery scheduled and there was no delay in initial surgery.
|
|
Manufacturer Narrative
|
Outcomes attributed to adverse event: other : revision surgery scheduled.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient for dlif spinal therapy at l2-5.It was reported that broken cage remains in patient. there was fragment of the implant or instrument remaining in the patient. there was no patient symptom reported.There were no further complications reported regarding the event.Additional information received states that revision surgery scheduled and there was no delay in initial surgery.
|
|
Search Alerts/Recalls
|