MAUDE Adverse Event Report: PRECISION SPINE, INC REFORM POCT SYSTEM; PEDICLE SCREW

Catalog Number 55-PA-XXXX

Device Problem Material Deformation (2976)

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

Event Date 06/12/2023

Event Type  Injury  

Event Description

It was reported that during a procedure performed on (b)(6) 2023, the tulip threads of two (2) reform poct polyaxial screw t15 stripped upon final tightening the lock screws.The screws were removed and replaced.There was no patient injury or extensive delay to the procedure as a result of the malfunction.

Manufacturer Narrative

H3 device evaluation - although the information provided indicates that the product is available for evaluation, it has not yet been received by the manufacturer.Without lot identification, device history record review, and complaint history review is not possible.Without the opportunity to examine the device, no conclusions can be drawn as to the cause of the reported malfunction.Should the product be received, upon completion of evaluation, a follow up report will be submitted.This report is number 1 of 2 mdrs filed for the same event (reference (b)(4)).

• Brand Name: REFORM POCT SYSTEM
• Type of Device: PEDICLE 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: 17291732
• MDR Text Key: 318739743
• Report Number: 3005739886-2023-00027
• Device Sequence Number: 1
• Product Code: NKG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162300
• 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: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 55-PA-XXXX
• Was Device Available for Evaluation?: Yes
• 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
• Patient Outcome(s): Required Intervention