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

Catalog Number 55-SC-5500

Device Problem Fracture (1260)

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

Event Type  Injury  

Manufacturer Narrative

H3 other - evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.This report is number 2 of 2 mdrs filed for the same event (reference 3005739886-2023-00045 / 00046).

Event Description

Two broken straight cocrmo rods, 5.50 x 500mm (39-sc-5500) were returned indicating that both broke in the patient a few months post-op.Attempts to obtain further details have been unsuccessful to date.

Event Description

It was reported that the patient was originally implanted approximately one year ago.Subsequently, patient presented with pain and a revision was performed in (b)(6) 2023 to address broken rods on a thirteen level construct.There was no report of trauma.

Manufacturer Narrative

H3 device evaluation - five rod segments were returned.Eight or nine potential fracture sites are present.Rod fractures were examined with the aid of a loop or with a low magnification scope.Some fracture surfaces consist of shiny regions above and below the center region.The shiny regions are believed to be due to the broken surfaces rubbing against each other with the duller segment being the last region to fracture.Some surfaces exhibit significant marring across the entire fracture surfaces.Beach marks are present and readily discernible on some of the surfaces.Beach marks indicative of fatigue failure.Some of these failures are just above or below attachment locations which are determined via lock screw markings on the rod surface.The cause for the rod failures is believed to be related to fatigue loading conditions with proper fusion not obtained over approximately a year long period.Review of device history records is not possible without lot identification, which was not provided nor could it be obtained from the pieces of the product returned.Two-year complaint history review (9.8.2021-9.8.2023) found this to be the only report of fracture for this part number.No corrective actions are being recommended currently.This report is number 2 of 2 mdrs filed for the same event (reference 3005739886-2023-00045-1 / 00046-1).

• Brand Name: REFORM PEDICLE SCREW SYSTEM
• Type of Device: ROD
• 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: 17827941
• MDR Text Key: 324399103
• Report Number: 3005739886-2023-00046
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 00840019901703
• UDI-Public: 00840019901703
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143248
• 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,Followup
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 55-SC-5500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2023
• Date Manufacturer Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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