MAUDE Adverse Event Report: PRECISION SPINE, INC. VAULT C ACDF SYSTEM; INSERTER

Model Number	37-IN-0010
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown.Occupation: other; distributor.Device evaluation: information provided indicates that the product is available for evaluation but has yet to be received.Review of device history records found fifteen (15) pieces of lot 1213im were released for distribution on 7/9/2014 with no deviation or anomalies.Two-year complaint history review found this to the only report for this part number.No conclusions can be drawn at this time regarding the cause of the reported event.Should the product be received, a follow-up medwatch report will be submitted following completion of the investigation.
Event or Problem Description
During a procedure performed in (b)(6) on an unknown date, the implant insertion handle (37-in-0010) was getting stuck on the cage inside the disc space and difficult to detach.The procedure was successfully completed with no harm to the patient, but with a one (1) hour delay.
Additional Manufacturer Narrative
H3 device evaluation - engineering performed a visual inspection of the complaint product.There is no visible damage or deformity of the implant inserter handle instrument.The device history record for the 15 piece lot, confirms that the 15 piece lot had been inspected and conform to drawing specifications.Engineering tested the complaint product with mating component, guided inserter tip, 37-in-04xx, and vault-c assembled implant.Engineering was unable to reproduce the reported failure with mating parts.The guided inserter tip that was used during the surgery was not returned for further inspection.Therefore, a root cause could not be determined.Review of device history records found fifteen (15) pieces of lot 1213im were released for distribution on 7/9/2014 with no deviation or anomalies.Two-year complaint history review found this to be the only report for this part number.Further review back to the date of manufacture did not find any previous reports of this nature for this part number.As root cause could not be identified and there was not a trend for reports of this nature identified, the need for corrective action is not indicated.
Event or Problem Description
During a procedure performed in dubai on an unknown date, the implant insertion handle (b)(4) was getting stuck on the cage inside the disc space and difficult to detach.The procedure was successfully completed with no harm to the patient, but with a one (1) hour delay.

• Brand Name: VAULT C ACDF SYSTEM
• Common Device Name: INSERTER
• Manufacturer (Section D): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• MDR Report Key: 10868043
• Report Number: 3005739886-2020-00036
• Device Sequence Number: 19833992
• Product Code: LXH
• UDI-Device Identifier: 00840019916875
• UDI-Public: 00840019916875
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2020

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-IN-0010
• Device Catalogue Number: 37-IN-0010
• Device Lot Number: 1213IM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 01/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization