Model Number 10-C3208-13 |
Device Problems
Use of Device Problem (1670); Positioning Problem (3009)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 08/29/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
Reporter occupation - other; sales representative.Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.This report is number 2 of 3 mdrs filed for the same event (reference 3005739886-2022-00030 / 00032).
|
|
Event Description
|
It was reported that a procedure was performed on (b)(6) 2022, utilizing the vault alif system.The plate and cage were assembled on the back table.The set screw was torqued to assemble the plate and cage components.The assembly was then inserted into the disc space with four screws.Upon attempting to assemble the lock screw it was noted that it did not seem to fit as usual.An x-ray was then taken and it was noted the vault alif peek plate 32mm x 13mm 8 deg lordosis (10-p3208-13p) appeared to be skewed from the vault alif peek cage 32mm x 13mm 8 deg lordosis (10-c3208-13).The screws and plate/cage assembly were removed and replaced with others of the same size with no further issue.
|
|
Event Description
|
It was reported that a procedure was performed on (b)(6) 2022, utilizing the vault alif system.The plate and cage were assembled on the back table.The set screw was torqued to assemble the plate and cage components.The assembly was then inserted into the disc space with four screws.Upon attempting to assemble the lock screw it was noted that it did not seem to fit as usual.An x-ray was then taken and it was noted the vault alif peek plate 32mm x 13mm 8 deg lordosis (10-p3208-13p) appeared to be skewed from the vault alif peek cage 32mm x 13mm 8 deg lordosis (10-c3208-13).The screws and plate/cage assembly were removed and replaced with others of the same size with no further issue.
|
|
Manufacturer Narrative
|
H3 device evaluation - the 10-c3208-13 was returned w/ a hole cut into the face which mates w/ the peek plate.This may have been cut w/ a midas burr inter-operatively to aid with the cage's removal.As the complaint centers around a condition observed inter-operatively, being the plate and cage were skewed from one another, confirmation of the complaint cannot be achieved do to the lack of the inter-operative x-ray that was used to determine necessity to remove the cage.Also, the returned implants do not assist in complaint confirmation due to the damage noted.The complaint was unsubstantiated.Review of device history records (41203_10-c3208-13) found twenty-five (25) pieces of this lot released for distribution on 6/21/2022 with no deviation or anomalies.Two-year complaint history review found this to be the only complaint of this nature for any of the plate/cage part numbers in the vault alif family.This report is number 2 of 3 mdrs filed for the same event (reference 3005739886-2022-00030-1 / 00032-1).
|
|
Search Alerts/Recalls
|