MAUDE Adverse Event Report: DEPUY SPINE INC UNKNOWN RODS; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Device Problem Break (1069)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 10/11/2019

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown rod/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after the review of the following journal: adogwa o, et al.(2020), comparison of rod fracture rates in long spinal deformity constructs after transforaminal versus anterior lumbar interbody fusions: a single-institution analysis, j neurosurg spine, volume 32, pages 42-49, (usa).The primary aim of this study was to compare unilateral and bilateral rod fracture rates (with an emphasis on bilateral rod fractures) at final follow-up in patients undergoing tlif or alif procedures at the caudal levels of long fusion constructs.The secondary aim was to assess radiographic and patient-reported outcome (pro) at the 2 year follow-up.Between january 2006 and december 2014, 198 adult patients with a diagnosis of asd (adult idiopathic scoliosis and/or degenerative scoliosis) who underwent 5 or more level fusion to the sacrum with iliac fixation were included in the study.There were 20 males and the rest were females.The mean age was 55.75 +/-11.05 years.The patients were divided into 2 groups whether they had undergone anterior lumbar interbody fusion (alif) or transforaminal lumbar interbody fusion (tlif) procedures.There were 65 patients (4 males and the rest were females, mean age of 52.95+/-9.37 years) who underwent alif procedures and were implanted with an unknown depuy spine peek cages and rhbmp-2.Meanwhile, 133 patients underwent tlif procedures with a competitor¿s device.The mean radiographic follow-up was 62.23 months (tlif 54.60 months, alif 77.85 months).Complications were reported as follows: 8 patients had unilateral rod fractures.1 of these patients underwent revision surgery.3 patients had bilateral rod fractures and underwent revision surgery.These patients had pseudoarthrosis on ct scan, loss of radiographic correction and deterioration of srs domains.This report is for the unknown depuy spine peek cages rods.

• Brand Name: UNKNOWN RODS
• Type of Device: ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 11773738
• MDR Text Key: 262623156
• Report Number: 1526439-2021-00892
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention