MAUDE Adverse Event Report: PRECISION SPINE, INC. REFORM POCT SYSTEM; POLYAXIAL SCREW

Model Number	55-PA-3526
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight, ethnicity, and race information - unknown.Occupation - other; sales representative.Device evaluated by mfr - 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 a procedure was performed by on (b)(6) , 2022, utilizing the reform poct pedicle screw system.During attempted insertion of one ø3.5 x 26mm polyaxial screw (55-pa-3526) the screw broke.Due to the location of the break, it was not possible to remove, so the distal portion of the broken screw was left in the patient's pedicle.Five (5) additional screws, 2 rods and 5 locking caps were successfully implanted with no further issue.There was no patient harm or meaningful delay to the procedure resulting from the broken screw.
Event or Problem Description
It was reported that a procedure was performed by on (b)(6) 2022, utilizing the reform poct pedicle screw system.During attempted insertion of one ø3.5 x 26mm polyaxial screw (55-pa-3526) the screw broke.Due to the location of the break, it was not possible to remove, so the distal portion of the broken screw was left in the patient's pedicle.Five (5) additional screws, 2 rods and 5 locking caps were successfully implanted with no further issue.There was no patient harm or meaningful delay to the procedure resulting from the broken screw.
Additional Manufacturer Narrative
H3 device evaluation - the screw is fractured approximately 11mm below the bottom of the tulip.A review of cad models indicates that approximately 15.5mm of screw length remains in the patient.The break is at the root of the thread and is in a plane that is nearly perpendicular to the screw's longitudinal axis.This failure is what would be expected in a torsional overload condition.It was noted that the cavity had been tapped but based upon the failure mode it appears that excess torque was applied in an effort to seat the screw.The reason for the need to apply high torque after tapping is not clear so the cause remains unknown.Review of device history records found (b)(4) pieces of lot 39562ps released for distribution on 2/10/2022 with no deviation or anomalies.Two-year complaint history review did not reveal a trend for reports of this nature for this part number.No corrective actions are being recommended at this time.

• Brand Name: REFORM POCT SYSTEM
• Common Device Name: POLYAXIAL 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: 15846717
• Report Number: 3005739886-2022-00038
• Device Sequence Number: 5390620
• Product Code: NKG
• UDI-Device Identifier: 00815362024003
• UDI-Public: 00815362024003
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K172495
• 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): 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 55-PA-3526
• Device Catalogue Number: 55-PA-3526
• Device Lot Number: 39562PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2022
• 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: 11/01/2022
• Supplement Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 11/22/2022
• Supplement Report FDA Received Date: 01/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2022
• 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
• Patient Age: 73 YR
• Patient Sex: Unknown