MAUDE Adverse Event Report: DEPUY SPINE INC UNKNOWN CAGE/SPACER; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR

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

Patient Problems Fatigue (1849); Paralysis (1997)

Event Type  Injury  

Manufacturer Narrative

Patient identifier, age or date of birth, sex, and weight: there are multiple patients all information is provided in the article.This report is for an unknown cage/spacer/unknown lot.Part and lot number are unknown; udi number is unknown.Implant date is between may 2009 and june 2011.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Device evaluated by mfr: 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 article: sakaura h., et al (2016) lifestyle-related diseases affect surgical outcomes after posterior lumbar interbody fusion, global spine j volume 6, pages 2¿6 (japan).This study aims to examine whether these lifestyle-related diseases affect clinical outcomes and fusion status after plif.Between may 2009 and june 2011, 122 consecutive patients (49 men, 73 women; mean age at time of surgery, 69.3 years; age range, 20 to 86 years) who underwent single-level plif for unstable degenerative lumbar spinal disorders were included in the study.The plif procedure was performed using the brantigan i/f cages (depuy spine, inc., raynham, massachusetts, united states).After the intervertebral disk material and cartilaginous end plates were removed, two cages were inserted into the intervertebral space, patients were followed up for 2 years.The following complications were reported as follows: collapsed fusion occurred in 48 patients.Nonunion was found in 10 patients.Surgery-related complications occurred in 14 patients: transient radicular pain occurred in 6 patients whose leg pain had been alleviated with oral medication.Delayed wound healing was noted in 1 patient whose wound successfully healed with debridement and resuture by 3 weeks after surgery.Four patients required revision surgery for evacuation of an epidural hematoma after the initial surgery.Two patients developed a deep wound infection; both patients were successfully treated with debridement and irrigation without removal of the implants.Transient motor weakness occurred in 1 patient this patient developed mild motor weakness of the left tibialis anterior just after surgery, and her mild paralysis had recovered fully with rehabilitation by 3 postoperative months.This report is for an unknown synthes brantigan i/f cages.This report is for one (1) unknown cage/spacer.This is report 3 of 4 for (b)(4).

• Brand Name: UNKNOWN CAGE/SPACER
• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR
• 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: 11837166
• MDR Text Key: 264717668
• Report Number: 1526439-2021-00960
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• 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: 04/20/2021
• 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