MAUDE Adverse Event Report: GS MEDICAL CO, LTD GSS; SPINAL PEDICLE FIXTATION

Model Number GS0161-0080, GS0161-0090

Device Problem Defective Device (2588)

Patient Problem Injury (2348)

Event Date 08/23/2016

Event Type  Injury  

Manufacturer Narrative

A letter was provided, on 12/1/2016, by a representative of the patent that did not provide details of the issue that occured with patient other than what was indicated in this report.The letter did indicated the following product was involved : g50104-0010 - set screw.G0120-0050 - large adjustable cross link.G50131-0080 - 80mm curved rod.G50161-0090 - 90mm curved rod.G50161-0080 - 80mm curved rod.Based on the information that was provide gs medical was not sure if the product indicated was their product.After further investigation, the healthcare facility was identified (i.E., (b)(6)), which was linked to the patient's name.From a packing slip to healthcare account and an additional dialog from the representative the following products were involved in the reported issue: gs0161-0080 - pre-bent rod (normal) dia.6.0 x 80mm.Gs0161-0090 - pre-bent rob (normal) dia, 6.0 x 90mm.No lot traceability was provided thus internal investigation through manufacturing records (i.E., dhrs) or confirmation studies could be conducted.The complaint product was not provided to manufacturer for investigation.Without a detail complaint description, the investigation could not be completed beyond what is indicated above.

Event Description

An individual to recover for the serious damages and injury sustained as a result of an accident caused by defective product.

Manufacturer Narrative

On august 8, 2017 additional information was provided through the manufacturer's legal counsel: the medical records were disclosed and the patient underwent 3 surgeries to address her degenerative scoliosis, on (b)(6) 2015, (b)(6) 2015, and (b)(6) 2016.Gs medical's product were implanted during each surgery.The surgeries are briefly described below: on (b)(6) 2014 - bilateral posterolateral spinal fusion to address degenerative spinal fusion to address degenerative scoliosis, performed by dr.(b)(6) at (b)(6).On (b)(6) 2015 - revision surgery related to nonunion at the l5-s1 space with loosening of fixation.The patient was admitted for re-fusion surgery, performed by dr.(b)(6) at (b)(6).On (b)(6) 2016 - revision surgery was performed.The lower rods from the (b)(6) 2015 surgery had fractured; they were removed and new rods were implanted.The pathology lab for (b)(6) did not receive the explanted devices.The devices may have been discarded in the operating room.

Event Description

An individual to recover for the serious damages and injury sustained as a result of an accident caused by defective product.Note: this was the description of the event reported on mdr 3005596514-2017-00001.Additional information was provided to the mfg on 8/8/2017 that identified that issue to be the lower rods were observed fractured during a revision surgery conducted on (b)(6) 2016.The rods were implanted in a revision surgery conducted on (b)(\6) 2015.

• Brand Name: GSS
• Type of Device: SPINAL PEDICLE FIXTATION
• Manufacturer (Section D): GS MEDICAL CO, LTD; 90, osongsaengmyeong 4-ro,; osong, heungdeok-gu; cheongju-si, chungcheonbugdo 28161 , KS; KS 28161, KS
• Manufacturer (Section G): GS MEDICAL CO, LTD; 90, osongsaengmyeong 4-ro; osong, heungdeok-gu; cheongju-si, chungcheonbugdo 28161 , KS; KS 28161, KS
• Manufacturer Contact: young sik park ; 90, osongsaengmyeong 4-ro; osong, heungdeok-gu; cheongju-si, cheongcheonbug 28161-, KS ; KS 28161, KS
• MDR Report Key: 6705091
• MDR Text Key: 79732918
• Report Number: 3005596514-2017-00001
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: GS0161-0080, GS0161-0090
• Device Catalogue Number: GS0161-0080, GS0161-0090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2016
• 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