MAUDE Adverse Event Report: PRECISION SPINE, INC. INTERVERTEBRAL BODY FUSION DEVICE; SCREWDRIVER

Model Number	10-1021
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information - unknown.Lot number - unknown.Occupation - other: distributor.Device manufacture date - unknown.Device evaluation - information provided indicates that the device is available for evaluation, but has yet been received by the manufacturer.Upon receipt and completion of investigation, a follow-up medwatch report will be submitted.No conclusions can be drawn at this time.
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2019, utilizing the vault alif system.Upon assembly of the plate to the cage the tip of the vault alif t8 tapered screwdriver (10-1021) broke in the set screw.The tip was removed from the screw and the procedure proceeded without delay.
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2019, utilizing the vault alif system.Upon assembly of the plate to the cage the tip of the vault alif t8 tapered screwdriver (10-1021) broke in the set screw.The tip was removed from the screw and the procedure proceeded without delay.
Additional Manufacturer Narrative
Device was not received by the manufacturer.Without the ability to examine the complaint product, or review device history records, no conclusions can be drawn regarding the root cause of the reported tip failure.Two-year complaint history review did not identify a trend for reports of this nature for the reported part number.As root cause could not be determined, and there was not a trend for reports of this nature for this part number, the need for corrective action was not indicated.

• Brand Name: INTERVERTEBRAL BODY FUSION DEVICE
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• MDR Report Key: 9461266
• Report Number: 3005739886-2019-00050
• Device Sequence Number: 16654258
• Product Code: HXX
• UDI-Device Identifier: 00840019922265
• UDI-Public: 00840019922265
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10-1021
• Device Catalogue Number: 10-1021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 06/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1