MAUDE Adverse Event Report: PRECISION SPINE, INC REFORM TI MODULAR; MODULAR BONE SCREW

Model Number	39-SK-6540
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2023, by dr.(b)(6) utilizing the reform ti modular pedicle screw system.The scrub tech assembled the ø6.5mm x 40mm reform ti modular cannulated screw (39-sk-6540) and the reform ti modular tower tulip (39-mt-0403) on the back table.Following assembly, she pushed and pulled on the tulip prior to loading on the driver.The surgeon then inserted the k-wire with a mazar robot on the right side and inserted screws in both l4 & l5 and then inserted left side screws.The rod was placed on the left side, locking caps were assembled and torqued.The physician assistant was then using the gold shaft height adjuster and when the height adjuster was pulled off, the tulip had disassembled and was still in the adjuster.The pedicle screw was then removed and replaced with a new screw/tulip assembly of the same size and the procedure was completed with no further incident.There was no patient injury, but a 2 1/2 minute delay to the procedure.
Additional Manufacturer Narrative
H3 device evaluation - both the screw and tulip were returned.Both parts were visually examined by eye prior to assembling.There are no signs of clamping on the bone screw sphere.The parts were able to be successfully assembled per the design intent and then the tulip and screw were simultaneously tugged on in an effort to disassemble.The parts do not exhibit any signs that they would be prone to disassembly.Review of device history records found 150 pieces of this lot released for distribution on 02/01/2023 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 since the parts appear to function per the design intent.However, it is unclear as to why the disassembly occurred.This report is number 2 of 2 mdrs filed for the same event (reference 3005739886-2023-00035 ).
Additional Manufacturer Narrative
Although there was no product non-conformance identified, corrective actions will be implemented by marketing to update the surgical technique guide to add additional instruction for tulip assembly and also develop a training video for the sales force that will include detailed assembly techniques.This report is number 2 of 2 mdrs filed for the same event (reference 3005739886-2023-00035-1).
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2023, utilizing the reform ti modular pedicle screw system.The scrub tech assembled the ø6.5mm x 40mm reform ti modular cannulated screw (39-sk-6540) and the reform ti modular tower tulip (39-mt-0403) on the back table.Following assembly she pushed and pulled on the tulip prior to loading on the driver.The surgeon then inserted the k-wire with a mazar robot on the right side and inserted screws in both l4 & l5 and then inserted left side screws.The rod was placed on the left side, locking caps were assembled and torqued.The physician assistant was then using the gold shaft height adjuster and when the height adjuster was pulled off, the tulip had disassemble and was still in the adjuster.The pedicle screw was then removed and replaced with a new screw/tulip assembly of the same size and the procedure was completed with no further incident.There was no patient injury, but a 2 1/2 minute delay to the procedure.

• Brand Name: REFORM TI MODULAR
• Common Device Name: MODULAR BONE SCREW
• Manufacturer (Section D): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• Manufacturer (Section G): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• Manufacturer Contact: mike dawson ; 2050 executive drive; pearl, MS 39208 ; 6014204244
• MDR Report Key: 17365404
• Report Number: 3005739886-2023-00036
• Device Sequence Number: 5227705
• Product Code: KWP
• UDI-Device Identifier: 00840019933612
• UDI-Public: 00840019933612
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K150856
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2023

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: 39-SK-6540
• Device Catalogue Number: 39-SK-6540
• Device Lot Number: 42758PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2023
• Supplement Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 08/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• 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