MAUDE Adverse Event Report: PRECISION SPINE, INC VAULT C ACDF SYSTEM; ANTERIOR PLATE

Model Number	37-PA-4207
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient -age or date of birth, sex, weight and race- unknown.Initial reporter occupation - other; sales representative.Device evaluated by mfr- evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.This report is number 2 of 2 mdrs filed for the same event (reference 3005739886-2023-00001).
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2022, utilizing the vault c acdf system.The surgeon inserted the assembled 14 x 12 x 07mm anterior plate (37-pa-4207) and 14 x 12 x 07mm 7° posterior peek cage (37-cl-4207).When he attempted to removed the inserter/guide tip from the plate cage assembly, the streamline insertion tip (37-in-0428) would not release, resulting in the plate being pulled off of the cage.The doctor then had to remove the cage from the disc space and replace with a new plate/cage assembly.There was no patient injury but there was a five (5) minute delay to the procedure.
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2022, utilizing the vault c acdf system.The surgeon inserted the assembled 14 x 12 x 07mm anterior plate (37-pa-4207) and 14 x 12 x 07mm 7° posterior peek cage (37-cl-4207).When he attempted to removed the inserter/guide tip from the plate cage assembly, the streamline insertion tip (37-in-0428) would not release, resulting in the plate being pulled off of the cage.The doctor then had to remove the cage from the disc space and replace with a new plate/cage assembly.There was no patient injury but there was a five (5) minute delay to the procedure.
Additional Manufacturer Narrative
H3 device evaluation - engineering performed a visual inspection of the complaint products.There is no visible damage to the streamline inserter tip instrument.There is no visible damage or deformity to the anterior plate implant.The inserter tip does not open wide enough to release the anterior plate component.The engineering drawing for the inserter tip, 37-in-04xx, specifies that the tabs should be bent to a width of 0.550" - 0.560".The complaint product was measured by quality to confirm the tab width with results as follows: 0.525", 0.523", 0.525".The possible cause for the tab width to be undersized is if the inserter tip was compressed in the implant inserter handle without being placed on the mating implant.This would cause the tabs to bend too far closed and therefore, it is no longer able to open far enough to release the implant.Review of device history records found (b)(4) pieces of this lot released for distribution on 6/29/2020 with no deviation or anomalies.Two-year complaint history review (12.14.2020-12.14.2022) found this to be the only report of this nature for this part number.Root cause is identified as normal wear / tear.No corrective actions are recommended.This report is number 2 of 2 mdrs filed for the same event (reference 3005739886-2023-00001-1 / 00002-1).

• Brand Name: VAULT C ACDF SYSTEM
• Common Device Name: ANTERIOR PLATE
• Manufacturer (Section D): PRECISION SPINE, INC; 2050 executive drive; 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: 16112009
• Report Number: 3005739886-2023-00002
• Device Sequence Number: 5846816
• Product Code: OVE
• UDI-Device Identifier: 00840019903837
• UDI-Public: 00840019903837
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K132029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2022

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: 37-PA-4207
• Device Catalogue Number: 37-PA-4207
• Device Lot Number: 37228PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2022
• 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: 12/14/2022
• Supplement Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 01/06/2023
• Supplement Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2021
• 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