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

Model Number	SLP6535
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information - unknown.Occupation - other; distributor.Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.
Event or Problem Description
It was reported that the patient underwent initial implantation on (b)(6) 2021, during which surelok pedicle screw system product was implanted.Subsequently, a revision procedure was performed in (b)(6) on (b)(6) 2021, to address a broken 6.5mm x 35mm s-lok polyaxial screw (slp6535).As confirmed by the surgeon, fusion was achieved at the time of the revision procedure.
Additional Manufacturer Narrative
H3 device evaluation - the x-rays and the returned part were reviewed.The broken screw appears to be one of the two screws placed in the sacrum.The number of levels being fused is unclear since the image is truncated.At least three levels are shown.The screw's fractured surface was examined with the aid of a 5x loop.The surface near the area of crack progression includes a few ratchet marks.Crack progression marks emanate from this side of the screw.Based upon the markings fatigue failure is suspected.The cause for the failure is unknown but numerous clinical papers are associated with hardware failures across the lumbo-sacral junction.Review of device history records found forty (40) pieces of lot 31973ps were released for distribution on 8/27/2020 with no deviation or anomalies.Two-year complaint history review (9.28.209-9.28-2021) found this to be the only report of this nature for the reported lot.Further review did not reveal a trend for reports of this nature for the reported product family of screws.No corrective actions are recommended at this time.
Event or Problem Description
It was reported that the patient underwent initial implantation on (b)(6) 2021, during which surelok pedicle screw system product was implanted.Subsequently, a revision procedure was performed in puerto rico on (b)(6) 2021, to address a broken 6.5mm x 35mm s-lok polyaxial screw (slp6535).As confirmed by the surgeon, fusion was achieved at the time of the revision procedure.

• Brand Name: PSS SYSTEM
• Common Device Name: BONE SCREW
• Manufacturer (Section D): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• Manufacturer (Section G): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• Manufacturer Contact: mike dawson ; 2050 executive dr; pearl, MS 39208 ; 6014204244
• MDR Report Key: 12674412
• Report Number: 3005739886-2021-00054
• Device Sequence Number: 3707036
• Product Code: MNH
• UDI-Device Identifier: 00840019913645
• UDI-Public: 00840019913645
• Combination Product (Y/N): N
• Initial Reporter Country: DR
• PMA/510(K) Number: K092128
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2021

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: SLP6535
• Device Catalogue Number: SLP6535
• Device Lot Number: 31973PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/28/2021
• Supplement Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown