MAUDE Adverse Event Report: U&I CORPORATION PERFIX SPINAL FIXATION SYSTEM

Catalog Number SNM7550

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Stenosis (2263)

Event Date 10/17/2017

Event Type  Injury  

Manufacturer Narrative

The two pedicle screws were evaluated.Chemical composition of them was within acceptable range specified in astm f136 standard and their measurements were within tolerance specified in the engineering drawing.The loosening and fracture of pedicle screws were because of the nonunion.

Event Description

Patient underwent surgery to treat lumbar spinal stenosis on (b)(6) 2015, but the pedicle screws were loose at l5 post-operatively.The loose screws were replaced with larger pedicle screws and the construct was revised on (b)(6) 2017.Two pedicle screws replaced were fractured seven months later and the patient underwent the 3rd surgery on (b)(6) 2017.

• Brand Name: PERFIX SPINAL FIXATION SYSTEM
• Type of Device: SPINAL FIXATION SYSTEM
• Manufacturer (Section D): U&I CORPORATION; 20,sandan-ro, 76beon-gil; uijeongbu, gyeonggi-do 11781 ; KS 11781
• Manufacturer Contact: yeo su gil ; 20,sandan-ro,76beon-gil; uijeongbu, gyeonggi-do 11781 ; KS 11781
• MDR Report Key: 7023859
• MDR Text Key: 91845047
• Report Number: 9617297-2017-00005
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K091725
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: SNM7550
• Device Lot Number: 15B218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2015
• 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
• Patient Weight: 50