MAUDE Adverse Event Report: PRECISION SPINE, INC. SURELOK MIS 3L; PEDICLE SCREW

Model Number	63-CP-6540
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation - other; distributor.Device evaluation - information provided indicates that the product is available for evaluation but has yet been returned.Review of device history records found seventy-five pieces of lot 42166ps released for distribution on (b)(6) 2022 with no deviation or anomalies.Two-year complaint history review found this to be the only report for this part number.There was one additional report of this nature reported for a different part number in this family received from the same complainant as this report.Should the product be received, a follow-up medwatch report will be filed upon completion of investigation.
Event or Problem Description
It was reported that a 3 level mis tlif cage procedure was performed in jordan, utilizing the surlok mis 3l pedicle screw system.After full insertion of the sure-lok mis triple lead screw 6.5mm x 40 mm (63-cp-6540) while applying the rod/blocker the screw suddenly pulled out of the bone.Information provided indicates that the patient's bone stock was good and is not osteoperotic.A new screw was then implanted successfully.There was a delay to the procedure but unknown how long.
Event or Problem Description
It was reported that a 3 level mis tlif cage procedure was performed in jordan, utilizing the surlok mis 3l pedicle screw system.After full insertion of the sure-lok mis triple lead screw 6.5mm x 40 mm (63-cp-6540) while applying the rod/blocker the screw suddenly pulled out of the bone.Information provided indicates that the patient's bone stock was good and is not osteoperotic.A new screw was then implanted successfully.There was a delay to the procedure but unknown how long.
Additional Manufacturer Narrative
H3 device evaluation - examination was not possible, as the actual complaint product was not returned.Review of the device history records did not reveal any related manufacturing deviations or anomalies nor were there any out of specification conditions found on inventory returned from the same lot.The investigation could not verify or identify any evidence of product error contribution to the reported problem.Based on the investigation, the need for corrective action is not indicated.

• Brand Name: SURELOK MIS 3L
• Common Device Name: PEDICLE 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: 16541876
• Report Number: 3005739886-2023-00008
• Device Sequence Number: 17772369
• Product Code: MNH
• UDI-Device Identifier: 00840019905503
• UDI-Public: 00840019905503
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• PMA/510(K) Number: K141397
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2023

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: 63-CP-6540
• Device Catalogue Number: 63-CP-6540
• Device Lot Number: 42166PS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2023
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown