MAUDE Adverse Event Report: PRECISION SPINE, INC. PSS SYSTEM; PEDICLE SCREW

Model Number	SLP4540
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
User facility report #mw5091901 forwarded to the manufacturer by the fda.Patient information - not provided.Lot number - unknown.Device manufacture date - unknown.Device evaluation - the user facility report indicates that the device is available for evaluation but it has not been returned to the manufacturer.Follow-up with the user facility in attempt to obtain the device has been sent, but to date no response has been received.A root cause cannot be determined at this time, but information provided indicates that the doctor felt that the patient's bone quality was a likely contributing factor.Device history review is not possible without lot identity.Two-year complaint history review did not identify a trend for reports of this nature for this product family.Should the product be received or additional information be received, a follow-up medwatch report will be submitted.
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2019 utilizing the surelok pedical screw system.During the procedure an awl was used to prepare the patient's bone and upon attempted insertion of a 4.5mm x 40mm s-lok polyaxial screw (slp4540), the screw broke mid-shaft.All pieces of the screw were easily removed, the bone was then tapped and a larger diameter, 6.5mm x 40mm s-lok polyaxial screw was successfully implanted.It was noted that the patient had extremely hard bone.There was no delay to the procedure or patient injury.The surgeon attributed the screw breakage to the patient's hard bone.

• Brand Name: PSS SYSTEM
• Common Device Name: PEDICLE SCREW
• Manufacturer (Section D): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• MDR Report Key: 9687622
• Report Number: 3005739886-2020-00004
• Device Sequence Number: 18924086
• Product Code: MNH
• UDI-Device Identifier: 00840019913492
• UDI-Public: 00840019913492
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K092128
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/10/2020
• Report Date (Section F): 12/23/2019

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 Model Number: SLP4540
• Device Catalogue Number: SLP4540
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/23/2019
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 02/10/2020
• 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
• Date Report Sent to FDA: 12/23/2019