MAUDE Adverse Event Report: PRECISION SPINE, INC. REFORM HA COATED PEDICLE SCREW SYSTEM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	39-PH-7540-S
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information - unknown.Occupation - other: sales representative.Product evaluation: product evaluation was not possible as explanted product was not returned to the manufacturer.Review of device history record found (b)(4) pieces of this lot were released for distribution on 3/26/2018 with no deviation or anomalies and all devices were certified sterile prior to release.Two-year complaint history review found this to be the only report of this nature for this part number.Further review for all part numbers in the 39-ph-xxxx-s reform ha coated pedicle screw, sterile family found this to be the only report of infection found.The investigation could not verify or identify any evidence of product error contribution to the reported problem.There are warnings in the package insert that state that this type of event can occur.Ifu lbl-ifu-021, reform ha coated pedicle screw system, lists under possible adverse effects: 10.Infection.As this is the only report of this nature for this lot and the product was certified sterile prior to release, the need for corrective action was not indicated.This report is number 2 of 4 mdrs filed for the same event (reference 3005739886-2015-00030 / 00033).
Event or Problem Description
Information provided, along with sales history, indicates that the patient underwent a single level fusion procedure on (b)(6) 2019, utilizing the reform ha coated sterile pedicle screws.Subsequently, the patient presented with infection and procedures were performed (b)(6) 2019, (b)(6) 2019 & (b)(6) 2019.No details regarding these procedures were available, but based on sales history information, it appears that during the procedure performed on (b)(6) 2019 to address infection, four (4) reform ha coated pedicle screws 7.5mm x 40mm (lot 15351ps) that were implanted during the initial procedure were removed and replaced due to loosening caused by infection.

• Brand Name: REFORM HA COATED PEDICLE SCREW SYSTEM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• MDR Report Key: 8980998
• Report Number: 3005739886-2019-00031
• Device Sequence Number: 3288389
• Product Code: KWP
• UDI-Device Identifier: 00815362020234
• UDI-Public: 00815362020234
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K151422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/12/2019

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 Expiration Date: 02/09/2023
• Device Catalogue Number: 39-PH-7540-S
• Device Lot Number: 15351PS
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 09/10/2019
• 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; Required Intervention
• Patient Age: 79 YR