MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 54740006545

Device Problem Break (1069)

Patient Problems Pain (1994); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 11/06/2020

Event Type  malfunction  

Manufacturer Narrative

This part is not approved for use in the united states; however a like device catalog # 54840006545, 510k #k091974 and udi #: (b)(4) was cleared in the united state. Radiographic image result - post-op x-ray for l4-s1 posterior spinal interpretation. Pedicle screw at l4 to s1 are seen, an interbody graft is present at l4-s1. There appears to be screw loose present in the interbody space. Both of the s1 screws appear fractured. If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from healthcare professional via field representative regarding patient with l5 spondylolytic spondylolisthesis involved in l4-s(l5/s:plif) procedure used in spinal therapy. Levels implanted - l4 to s1ps. It was reported that during use, the screws of ps on both sides of s1 broke. The delay in overall procedure was less than 60 minutes. Additional surgery was performed to remove the broken screw. Revision surgery was performed to remove broken screw as patient felt back pain. It was reported they tried to remove the broken screw with pse1, but the removing was given up because the spinal canal was near and it would defeat the purpose if the nerve root is damaged. Device status reason : explanted-partial initial surgery - plif was performed at l5/s due to l5 spondylolytic spondylolisthesis. Ps was used at l4 since the pedicle of l5 was thin due to l5 pedicle aplasia and ps was difficult. On 2020-nov-17, received additional information that product that was collected after revision surgery will be returned. There was no pain reported after the re-operation.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 10910440
• MDR Text Key: 221291602
• Report Number: 1030489-2020-01700
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 54740006545
• Device Catalogue Number: 54740006545
• Device Lot Number: H5461598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial