MAUDE Adverse Event Report: PRECISION SPINE, INC. ANTERIOR LUMBAR PLATE SYSTEM; SCREWDRIVER

Model Number	ALP-35HS
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 1 of 2 mdrs filed for the same event (reference 3005739886-2021-00018 / 00019).
Event or Problem Description
It was reported that an anterior lumbar plate procedure was performed on (b)(6) 2021, utilizing the accufit alif plate system.While placing a screw the tip of two alp 3.5 hex screwdriver shafts (alp-35hs) stripped along with the head of the screw.The stripped screw was removed and replaced utilizing other instrumentation readily available.There was no harm to the patient, but a two (2) minute delay because of the driver tip failure.
Additional Manufacturer Narrative
H3 device evaluation - returned drivers were evaluated by distribution quality tech upon receipt, finding no visible damage to the driver tips and functional testing with a sample screw found them to both retain and freely turn the head of the tulip/screw.An engineering evaluation of the two returned drivers was performed using a 5.5mm x 35mm long screw and alp plate.Both drivers successfully retained the screw and were capable of securing the alp plate to a 15 pcf foam block.The screws were driven into the block sans a pilot hole to demonstrate worst case.Review of device history records found 54 pieces of this lot were released for distribution on (b)(6) 2012 with no deviation or anomalies.Complaint history review back to the date of manufacture found this to be the only report of this nature for the reported lot numbers.No corrective action is recommended at this time as the complaint cannot be confirmed.This report is number 1 of 2 mdrs filed for the same event (reference 3005739886-2021-00018-1 / 00019-1).
Event or Problem Description
It was reported that an anterior lumbar plate procedure was performed on (b)(6), 2021, utilizing the accufit alif platesystem.While placing a screw the tip of two alp 3.5 hex screwdriver shafts (alp-35hs) stripped along with the head of the screw.The stripped screw was removed and replaced utilizing other instrumentation readily available.There was no harm to the patient, but a two (2) minute delay because of the driver tip failure.

• Brand Name: ANTERIOR LUMBAR PLATE SYSTEM
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• MDR Report Key: 11581576
• Report Number: 3005739886-2021-00018
• Device Sequence Number: 2956003
• Product Code: HXX
• UDI-Device Identifier: 00840019925556
• UDI-Public: 00840019925556
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/02/2021

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: ALP-35HS
• Device Catalogue Number: ALP-35HS
• Device Lot Number: 1089IM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/02/2021
• Supplement Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 03/29/2021
• Supplement Report FDA Received Date: 06/24/2021
• 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: Required Intervention