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

Model Number	SLPL6540
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2021
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 a procedure was performed in the (b)(6) on (b)(6) 2021, utilizing the surelok pss pedicle screw system.When setting the lock screw in position it slipped and had no locking.Cross threading happened.The damaged pedicle screw was removed and replaced with another that was readily available in the set along with a new lock screw.The reported issue resulted in a fifteen (15) minute delay to the procedure.There was no patient injury.
Event or Problem Description
It was reported that a procedure was performed in the dominican republic on (b)(6) 2021, utilizing the surelok pss pedicle screw system.When setting the lock screw in position it slipped and had no locking.Cross threading happened.The damaged pedicle screw was removed and replaced with another that was readily available in the set along with a new lock screw.The reported issue resulted in a fifteen (15) minute delay to the procedure.There was no patient injury.
Additional Manufacturer Narrative
H3 device evaluation - the pedicle screws tulip threads were examined with the aid of a 5x loop as well as with a microscope.It appears that the tool that creates the internal break off geometry may have removed excess material as witnessed by a scalloping of the thread on one side of the tulip.The lock screw was also viewed with the aid of a 5x loop.Marring on the od of the threads indicates the lock screw either jumped a thread or was cross threaded.Other potential causes for marring on the tulip threads exist, so imaging by quality should be performed to confirm if the subject tulip is similar to other components identified on a capa.If a manufacturing issue is confirmed, actions in line with the capa should be taken.The complaint product was lost between being shipped back to pearl from the engineer and receipt by the complaint coordinator.Unable to confirm if the subject tulip is similar to a previous issue identified on specific lots of slpl screws.The subject tulip is not from one of the lots identified as part of the previous complaint / capa issue.Review of device history records found twelve (12) pieces of lot 12592ps were released for distribution on 2/9/2017 with no deviation or anomalies.Two-year complaint history review (2.2.2019-2.2.2021) found this to be the only report of this nature for the slpxxxx family of surelok pedicle screws.Further review back to the date of manufacture (2.9.2017) did not find any previous reports of this nature for the reported lot number.As the exact root cause could not be determined, the need for corrective action was not indicated.

• Brand Name: PSS 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: 11382077
• Report Number: 3005739886-2021-00014
• Device Sequence Number: 4567689
• Product Code: KWP
• UDI-Device Identifier: 00840019914093
• UDI-Public: 00840019914093
• Combination Product (Y/N): N
• Initial Reporter Country: DR
• PMA/510(K) Number: K092128
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2021

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: SLPL6540
• Device Catalogue Number: SLPL6540
• Device Lot Number: 12592PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• 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: 02/02/2021
• Supplement Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2017
• 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