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

Catalog Number 39-SB-65XX

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/22/2023

Event Type  malfunction  

Manufacturer Narrative

H3 device evaluation - without a product return, no product evaluation can be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.Without lot numbers, review of device history records and lot specific complaint history is not possible.Two-year complaint history review (7.27.2021-7.27.2023) found this to be the only complaint of this nature for both of the part numbers reported.This report is number 2 of 2 mdrs filed for the same event (reference 3005739886-2023-00038).

Event Description

It was reported that a procedure was performed byon (b)(6) 2023, utilizing the reform ti modular screw system.The scrub tech connected the reform ti modular polyaxial tulip assembly (39-mt-0401) to the 65mm reform ti modular non-cannulated screw (39-sb-xxxx), loaded the assembled screw/tulip on the driver and handed it to the surgeon.When the surgeon attempted to implant the screw, the tulip detached from the screw.The screw was taken to the back table and reassembled on a different screw and subsequently implanted successfully.There was no delay to the procedure or patient injury.

• Brand Name: REFORM TI PEDICLE SCREW SYSTEM
• Type of Device: 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: 17568837
• MDR Text Key: 321746585
• Report Number: 3005739886-2023-00039
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150856
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 39-SB-65XX
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1