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

Model Number	39-SK-6545
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	04/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2023, utilizing the reform ti mis pedicle screw system.The modular polyaxial tulip assembly (64-mt-0403) was popped onto the ø6.5mm x 45mm reform ti modular cannulated screw (39-sk-6545) in the caddy.The tech then pulled on the bone screw to check for proper assembly.The assembled screw and tulip was then inserted with the polyaxial screwdriver and when the screwdriver was removed from the screw the tulip head popped off the screw.At this time a new k-wire was inserted and the bone screw was backed out of the pedicle.Another screw and tulip were assembled and implanted with no further issue.There was a five (5) minute delay to the procedure due to this issue.
Additional Manufacturer Narrative
H3 device evaluation - both the screw and tulip were returned.Both parts were visually examined by eye prior to assembling.There were no signs of clamping on the bone screw sphere.Only slight scratching from an unknown cause.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.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.Review of device history records found (b)(4) pieces of this lot released for distribution on (b)(6) 2023 with no deviation or anomalies.Two-year complaint history review did not identify a trend for reports of this nature for this part number.This report is number 2 of 2 mdrs filed for the same event (reference 3005739886-2023-00018 / 00019).

• Brand Name: REFORM TI MODULAR
• Common Device Name: MODULAR BONE SCREW, CANNULATED
• 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: 16949974
• Report Number: 3005739886-2023-00019
• Device Sequence Number: 11588458
• Product Code: KWP
• UDI-Device Identifier: 00840019933629
• UDI-Public: 00840019933629
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/21/2023

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-6545
• Device Catalogue Number: 39-SK-6545
• Device Lot Number: 43069PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2023
• 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