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

Catalog Number	39-MT-0402
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	07/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 - device evaluation in process.A follow-up report will be submitted upon completion.
Event or Problem Description
It was reported that a patient underwent a procedure on (b)(6) 2024.Subsequently the patient presented with pain and x-rays found that one of the reform ti modular reduction tulip assembiles (39-mt-0402) disassembled from the ø7.5mm x 50mm reform ti modular non-cannulated screw (39-sp-7550).Revision procedure was performed on (b)(6) 2024, during which the tulip and screw shank were removed and replaced along with one rod component.
Event or Problem Description
It was reported that a patient underwent a procedure on (b)(6) 2024.Subsequently the patient presented with pain and x-rays found that one of the reform ti modular reduction tulip assemblies (39-mt-0402) disassembled from the ø7.5mm x 50mm reform ti modular non-cannulated screw (39-sp-7550).Revision procedure was performed on (b)(6) 2024, during which the tulip and screw shank were removed and replaced along with one rod component.
Additional Manufacturer Narrative
H3 device evaluation - the modular tulip was returned rigidly fixed to the rod with the lock screw clamping these two parts together.Considerable force was required to loosen the lock screw.It was confirmed that the tulip, lock screw, and rod assembly were as explanted.The bone screw had been implanted with a modular screwdriver and then the tulip was inserted onto the bone screw.It was not recalled if any significant force was being applied to the reduction tulip during the implantation process.The tulip and bone screw were subsequently assembled and clamped to the returned rod with the lock screw that was still in the modular tulip.The rod was held in a vice and the torque driver, torque wrench, and counter torque wrench were used to tighten the lock screw to the system torque setting.The screw remained assembled to the tulip and a rigid screw, tulip, rod assembly was attained.The tulip was rigidly fixed to the rod in the as explanted condition and therefore the screw was not secured in the tulip when final tightening was achieved.The tulip does not exhibit gross deformation of the tulip or snap ring components, and the functional assessment demonstrated the design functioned as intended.The cause for the tulip disassociation is unclear but it is believed that the tulip may not have been fully assembled to the screw at the time of implantation.Soft tissue or bone may have inhibited proper assembly.Review of device history records found 98 pieces of this lot released for distribution on 4/18/2024 with no deviation or anomalies.Two year complaint history review (7.23.2022-7.23.2024) found this to be the only report of this nature for this part number.No corrective actions are being recommended.

• Brand Name: REFORM TI MODULAR
• Common Device Name: MODULAR TULIP
• 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: 19961923
• Report Number: 3005739886-2024-00044
• Device Sequence Number: 8752279
• Product Code: KWP
• UDI-Device Identifier: 00840019932639
• UDI-Public: 00840019932639
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K150856
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2024

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 Catalogue Number: 39-MT-0402
• Device Lot Number: 48033PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2024
• 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