MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CLYDESDALE PTC¿ SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

Model Number 4986045

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/01/2022

Event Type  malfunction  

Manufacturer Narrative

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 pre-op diagnosis- degenerative scoliosis involved in the sacroiliac joint and thoracolumbar spine (lower spine, middle spine).Levels implanted- l2/3.It was reported that during operation, after inserting the cage to the l2/3 level, the inserter was reattached for additional insertion and the insertion was attempted, but it did not move, and the cage broke from the attachment part when hit with a hammer.Fragment remains in the patient body.Broken parts were collected and discarded (blood contamination).The cage main body was left in patient¿s body.There was no patient symptom reported.There were no further complications reported regarding the event.On 2022-feb-07, received additional information that there is no plan for revision surgery to explant the broken fragment from the patient's body.Fragment remained at the implanted level- l2/3.

• Brand Name: CLYDESDALE PTC¿ SPINAL SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• 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: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 13617184
• MDR Text Key: 289509017
• Report Number: 1030489-2022-00197
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00643169190733
• UDI-Public: 00643169190733
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133205
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4986045
• Device Catalogue Number: 4986045
• Device Lot Number: H5689262
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2022
• Initial Date FDA Received: 02/28/2022
• Date Device Manufactured: 08/11/2021
• 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 Sex: Female