MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. PYRAMESH IMPLANT SYSTEM; MESH, METAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Weakness (2145)

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

Patient demographics: no.Of patients- 9, gender- female (male- 4; female- 5), age (mean age)- 62 years, procedure involved: accf (anterior cervical corpectomy and fusion), anterior cervical discectomy and fusion (acdf), psf(posterior spinal fusion), corpectomy, anterior fixation a multi-center retrospective observational study was conducted to obtain post-market clinical data for medtronic spine implantable devices.This data was queried and grouped based on the specific medtronic system used in the surgical procedure and analyzed to establish real-world evidence (rwe) for the performance and safety of the device in question when used as part of standard clinical practice.This data collection is one part of ongoing post-market clinical surveillance activities that are intended to confirm and monitor the safety and performance of the device.This report summarizes the clinical data obtained by medtronic as part of this retrospective observational study for the pyramesh-c spinal system (hereafter referred to as pyramesh-c).The clinical data summarized in this report were extracted for analysis on march 23, 2020.Data obtained as part of this study was provided to in a de-identified format and thereby provides no patient or product specific identifiers.It was reported in the clinical titled ¿pyramesh-ctm spinal system¿ that a total of 9 patients met the minimal inclusion criteria of having a clinical diagnosis and documented surgical implantation of pyramesh-c.Based on the charted diagnoses, patients were stratified into one of four evidence groups: tumor (2), degenerative disease (n = 5), trauma (1), or deformity (1).Post-op, of the 02 patients in the tumor group, all 2 patients had radiographic notes specifying fusion status at the 3-month follow-up time point.The patients were not fused at the time of this assessment.However, 3 months is too early for a final fusion assessment, and longer-term follow-up is required.Of the 05 patient in the degenerative disease group, all 5 patients had radiographic notes specifying fusion status in at least one of the follow-up timepoints.Successful fusion was noted for 9 of the 9 patients at the last radiographic assessment specifying fusion status.Postoperative radiographic notes with fusion assessments were not available for the patient treated for deformity and trauma group.In the tumor group, 1 of 2 patients were recorded as having an ae.In total, 3 aes were recorded.The following are the adverse events reported in this group with the number of events mentioned in brackets "()": events related to continued thoracic/lumbar pain/discomfort: lower back pain (1).Events related to general surgery: surgical wound pain (1).Other aes that may be related to general surgery and/or spine surgery: weakness (1).In the degenerative disease group, 1 of 5 patients were recorded as having an ae.In total, 1 aes were recorded.The following are the adverse events reported in this group with the number of events mentioned in brackets "()": serious adverse events: death (1).One patient is reported to have expired.The cause of death and timing in relation to the spine surgical procedure are unknown.In the trauma and deformity group, there were no reported aes.Overall, within this limited patient population the pyramesh-c system performed as expected, and no safety risks were identified as part of this study.

• Brand Name: PYRAMESH IMPLANT SYSTEM
• Type of Device: MESH, METAL
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC.; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC.; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 10177479
• MDR Text Key: 201015056
• Report Number: 1030489-2020-00684
• Device Sequence Number: 1
• Product Code: EZX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/22/2020

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/26/2020
• Initial Date FDA Received: 06/22/2020
• Was Device Evaluated by Manufacturer?: No
• 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): Other
• Patient Age: 62 YR