MAUDE Adverse Event Report: PRECISION SPINE, INC. NEXGEN ANTERIOR CERVICAL PLATE SYSTEM; SCREWDIRVER

Model Number 65-IN-0730

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

Patient information: unknown.Occupation: distributor.Device evaluation: evaluation has not begun as, although information provided indicates that the device will be returned for evaluation, it has not yet been received by the manufacturer.Upon receipt and following completion of investigation, a follow-up medwatch report will be filed.

Event Description

It was reported that a procedure was performed on an unspecified date, utilizing the slimplicity hp acp system.Following insertion of a screw, the t10 self-retaining driver nexgen acp (65-in-0730) stuck in the head of the screw.The doctor jiggled the driver and it still did not disconnect from the screw, but pulled the screw out of the bone.A rescue screw that was readily available in the set was used to complete the procedure with no patient injury or delay to the procedure.

Manufacturer Narrative

H3 device evaluation - product was received at precision spine on 9/1/2020, the rma was not marked as a complaint, so the product was inspected, passed, and were returned to stock instead of being sent to regulatory for evaluation.When this was identified the product had already been back in active distribution for approximately six (6) months, distributed with no additional reported issues.With the returned parts passing the quality inspection, review of the device history records finding no anomalies, and the fact there are no additional reports of this nature, it would not be unreasonable to conclude that the complaint was an isolated incident that could not be repeated, and the product functions as required.Review of device history record found twenty-five (25) pieces of lot 00794up were released for distribution on 6/15/2020 with no deviation or anomalies.Two-year complaint history review (8.3.2018-8.3.2020) found this to be the only report for this part number.Further review of complaint history from 8.3.2020-3.24.2021 did not find any additional reports of this nature after receipt of the current report.No corrective action is recommended at this time.

Event Description

It was reported that a procedure was performed on an unspecified date, utilizing the slimplicity hp acp system.Follwing insertion of a screw, the t10 self-retaining driver nexgen acp (65-in-0730) stuck in the head of the screw.The doctor jiggled the driver and it still did not disconnect from the screw, but pulled the screw out of the bone.A rescue screw that was readily available in the set was used to complete the procedure with no patient injury or delay to the procedure.

• Brand Name: NEXGEN ANTERIOR CERVICAL PLATE SYSTEM
• Type of Device: SCREWDIRVER
• Manufacturer (Section D): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• MDR Report Key: 10461813
• MDR Text Key: 204705746
• Report Number: 3005739886-2020-00021
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 00840019937948
• UDI-Public: 00840019937948
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 08/03/2020

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
• Device Operator: Health Professional
• Device Model Number: 65-IN-0730
• Device Catalogue Number: 65-IN-0730
• Device Lot Number: 00794UP
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/03/2020
• Initial Date FDA Received: 08/27/2020
• Supplement Dates Manufacturer Received: 08/03/2020
• Supplement Dates FDA Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention