MAUDE Adverse Event Report: PRECISION SPINE, INC. INTERVERTEBRAL BODY FUSION DEVICE; INTERBODY CAGE ASSEMBLY, CAGE

Model Number	10-C3208-13
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/29/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem 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.
Additional 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).

• Brand Name: INTERVERTEBRAL BODY FUSION DEVICE
• Common Device Name: INTERBODY CAGE ASSEMBLY, CAGE
• Manufacturer (Section D): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• Manufacturer (Section G): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• Manufacturer Contact: mike dawson ; 2050 executive dr; pearl, MS 39208 ; 6014204244
• MDR Report Key: 15476647
• Report Number: 3005739886-2022-00031
• Device Sequence Number: 14755463
• Product Code: OVD
• UDI-Device Identifier: 00840019908276
• UDI-Public: 00840019908276
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K130445
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 10-C3208-13
• Device Catalogue Number: 10-C3208-13
• Device Lot Number: 41203PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2022
• Supplement Date Received by Manufacturer: 08/30/2022
• Initial Report FDA Received Date: 09/24/2022
• Supplement Report FDA Received Date: 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown