MAUDE Adverse Event Report: PRECISION SPINE, INC. MD-MAX ULIF SYSTEM; PEDICLE SCREW

Model Number	43-TL-6545
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation - information provided indicates that the product is available for evaluation but has yet been returned.Review of device history records was not possible without lot identity.Two-year complaint history review found this to be the only report of this nature for the reported part number.No conclusions can be drawn at this time.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 procedure was performed in jordan, utilizing the md max ulif system.During insertion the md-max triple lead polyaxial screw assembly 6.5 x 45mm (43-tl-6545) was stuck with no way to move it in or out.The screw was ultimately removed by force, once the incision was opened further.The surgeon chose not to attempt to implant another screw in this vertebrae.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.
Event or Problem Description
It was reported that a procedure was performed in jordan, utilizing the md max ulif system.During insertion the md-max triple lead polyaxial screw assembly 6.5 x 45mm (43-tl-6545) was stuck with no way to move it in or out.The screw was ultimately removed by force, once the incision was opened further.The surgeon chose not to attempt to implant another screw in this vertebrae.There was a delay to the procedure, but unknown how long.

• Brand Name: MD-MAX ULIF SYSTEM
• 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: 16541874
• Report Number: 3005739886-2023-00009
• Device Sequence Number: 17772368
• Product Code: MNI
• UDI-Device Identifier: 00840019915229
• UDI-Public: 00840019915229
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• PMA/510(K) Number: K122931
• 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: 43-TL-6545
• Device Catalogue Number: 43-TL-6545
• Device Lot Number: 39311PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/06/2021
• 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