MAUDE Adverse Event Report: MEDICREA INTERNATIONAL SA UNID; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number B33225512-02

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having posterior spinal fusion from t4 to the pelvis with s2ai screws using unid rods for alif l5-s1 (30 deg lordotic graft), spo l2-3.It was reported that the right unid rod broke around l4-l5 region and the broken portions are inside the patient and not yet explanted. the patient is planned to undergo revision surgery on (b)(6) 2021 to replace the broken rods.Due to broken rod there was loosening of the alif implant at l5-s1.The rod also lost some of its bend overtime and the patient had lost some correction.There were no patient symptoms reported.There were no further complications reported regarding the event.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received regarding the event.It was reported that from patient's x-rays it can be observed that the rod has been replaced and the surgeon added an extra fixture to secure/ stabilize the patient.Revision surgery was successfully completed on (b)(6) 2021 without any complications.Both rods were broken between l5 and s1 and they were completely explanted and replaced with new ones.There were no further complications reported regarding the event.

• Brand Name: UNID
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): MEDICREA INTERNATIONAL SA; 5389 rte de strasbourg; rillieux la pape,fr 69140 ; FR 69140
• Manufacturer (Section G): MEDICREA INTERNATIONAL SA; 5389 rte de strasbourg; rillieux la pape,fr 69140 ; FR 69140
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 12804241
• MDR Text Key: 285405793
• Report Number: 1000432246-2021-00011
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B33225512-02
• Device Catalogue Number: B33225512-02
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/15/2021
• Initial Date FDA Received: 11/12/2021
• Supplement Dates Manufacturer Received: 11/12/2021
• Supplement Dates FDA Received: 11/30/2021
• 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 Outcome(s): Required Intervention
• Patient Sex: Male