MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. CH HORIZON SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Device Problems Break (1069); Loose or Intermittent Connection (1371); Malposition of Device (2616); Material Protrusion/Extrusion (2979); Migration (4003)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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- 598, gender- female (female- 326; male- 270), age (mean age)- 55 years procedure involved: anterior cervical corpectomy and fusion (accf), anterior cervical discectomy (acdf), kyphoplasty, corpectomy, open reduction and internal fixation (orif), posterior spinal fusion (psf), anterior lumbar interbody fusion (alif), oblique lateral interbody fusion (olif), transforaminal lumbar interbody fusion (tlif), posterior lumbar interbody fusion (plif) 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.It was reported in the clinical study titled ¿cd horizon solera spinal system¿ with 24 months follow-up that a total of 598 patients met the minimal inclusion criteria of having a clinical diagnosis and documented surgical implantation of cdh solera.Based on the charted diagnoses, patients were stratified into one of seven evidence groups for analysis: degenerative disease (n = 419), trauma (n = 67), deformity (adult) (n = 41), failed fusion (n = 44), tumor (n = 10), deformity (pediatric) (n = 3), and infection (n = 14).Post-op, the following device related events were reported: in the degenerative disease group: cortical bone breach (3), graft migration/subsidence (2), hardware failure (13), hardware loosening (19), hardware migration (7), hardware protrusion (1), hardware removal (1), hardware subsidence (2), malpositioned hardware (5), and painful hardware (5).In the trauma group: cortical bone breach (2), displaced hardware (1), hardware failure (3), hardware loosening (3), hardware migration (1), malpositioned hardware (2).In the deformity group: hardware failure (7), hardware loosening (5).In the failed fusion group: cortical bone breach (1), hardware failure (5), hardware loosening (10), hardware migration (4), malpositioned hardware (3), painful hardware (1), protruding hardware (1).Due to this patient underwent a revision surgery.Overall, the results from this retrospective observational study indicate that cdh solera is performing as intended with failure and revision rates consistent with those reported in the literature for lumbar spine procedures.No new or emerging risks were identified.

• Brand Name: CH HORIZON SPINAL SYSTEM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• 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: 10156232
• MDR Text Key: 195312133
• Report Number: 1030489-2020-00630
• Device Sequence Number: 1
• Product Code: KWP
• 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: 06/15/2020

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2020
• Initial Date FDA Received: 06/15/2020
• 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): Required Intervention
• Patient Age: 55 YR