MAUDE Adverse Event Report: GENESYS SPINE GENESYS SCREW 6.5X45

Catalog Number G741-65-45

Device Problem Defective Device (2588)

Patient Problems Laceration(s) (1946); Pain (1994); Discomfort (2330)

Event Date 04/26/2016

Event Type  Injury  

Event Description

On or about (b)(6) 2016, patient had 360 lumbar fusion surgery from l4 to s1.A genesys screw system was implanted into patient's spine during the fusion surgery.Specifically, it was one genesys pedicle screw (size) 6.5x40, catalog number g741-65-40, lot number wt20151021a), two genesys screws (size 6.5x45, catalog number g741-65-45, lot number wt20151208b), and three genesys set screw caps (catalog number g826, lot number tw20160219).Approximately four months after the fusion surgery, patient was having a rough time with pain in the back, around the area of the incision and felt miserable.After the fusion surgery, it was discovered that the patient's problems were probably secondary to painful genesys hardware.On (b)(6) 2017, patient had lumbar genesys hardware removal surgery.The admitting diagnosis was a "mechanical complication" with patient's genesys hardware.The genesys hardware and screws were visibly defective because the genesys screw system did not have a flat, smooth, and slick surface on the head of each screw.This defect prevented seamless movement of patient's muscle tissue, nerves and skin across the top of each screw after implantation.This defect caused patient to suffer painful internal lacerations of muscle tissues, nerves, and skin with each bodily movement for approximately nine months.

• Brand Name: GENESYS SCREW 6.5X45
• Type of Device: GENESYS SCREW 6.5X45
• Manufacturer (Section D): GENESYS SPINE
• MDR Report Key: 6629472
• MDR Text Key: 77309837
• Report Number: MW5070252
• Device Sequence Number: 2
• Product Code: MNH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/07/2017
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: G741-65-45
• Device Lot Number: WT20151208B
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 38 YR
• Patient Weight: 91