MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. CRESCENT SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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

Patient Problems Death (1802); Respiratory Failure (2484)

Event Type  Death  

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.Although it is unknown if the device caused or contributed to the reported death or not, we are filing this report for notification purposes.If information is provided in the future, a supplemental report will be issued.

Event Description

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.Data obtained as part of this study was provided to in a de-identified format and thereby provides no patient or product specific identifiers.Patient demographics: no.Of patients- 42, gender- female(male- 19, female-23), age- 66.21 years pre op diagnosis: degenerative disease (29 patients), failed fusion (2 patients), deformity (11 patients) procedure involved: plif; psf, psf, tlif, tlif; psf, levels implanted: lumbar, lumbar; sacral, thoracic; lumbar, thoracic; lumbar; sacral.It was reported in clinical study that a total of 42 patients met the minimal inclusion criteria of having a clinical diagnosis and documented surgical implantation of spinal system.Based on the charted diagnoses, patients were stratified into one of three evidence groups for analysis: degenerative disease (n = 29), failed fusion (n = 2), and deformity (n = 11).Summary data of postoperative radiographic notes with fusion assessments were available for 6-months, 12-months, and 24-months follow-up time points.Of the 29 patients in the degenerative disease group, 19 patients had radiographic notes specifying fusion status in at least one of the follow-up time points.For patients with fusion status recorded at 12- and 24- month follow-up, 13 of 14 (92.9%) and 4/4 (100%) were noted as having a successful fusion, respectively.Successful fusion was indicated for 17 of the 19 patients at the last available radiographic assessment noting fusion status.Both patients in the failed fusion group were recorded as having a successful fusion at 12 -months post-operative.Of the 11 patients in the deformity group, 8 had radiographic notes specifying fusion status in at least one of the follow-up time points.Successful fusion was indicated for 8 of 8 (100%) patients at the last available radiographic assessment noting fusion status.In the degenerative disease group, 16 of 29 patients were recorded as having an adverse event.38 aes of 26 different type were reported.2 patients expired.One patient expired due to secondary to cardio-respiratory failure 7 months post-operative initial surgery and 5 months post-operative underwent a revision surgery.And second patient expired 6 months post-operative for unknown reasons.Overall, the results from this retrospective observational study indicate that the concerned spinal system is safe and effective when used as intended.No new or emerging risks were identified.

• Brand Name: CRESCENT SPINAL SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• 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: 10193813
• MDR Text Key: 196379335
• Report Number: 1030489-2020-00718
• Device Sequence Number: 1
• Product Code: NKB
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2020
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention