MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - CONSTRUCTS: VIPER; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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

Patient Problems Fever (1858); Sepsis (2067); Convulsion/Seizure (4406); Unspecified Mental, Emotional or Behavioural Problem (4430)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown mono/ polyaxial screws/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 article: jazini, e.Et al (2017), outcomes of lumbopelvic fixation in the treatment of complex sacral fractures using minimally invasive surgical techniques, the spine journal, vol.17 (xx), pages 1238¿1246 (usa).The aim of this retrospective cohort study is to review our institution¿s experience with minimally invasive lpf as a supplemental stabilization method for the treatment of complex sacral fractures with and without unstable pelvic ring injuries.Between 2008 to 2014, a total of 24 patients (12 male and 12 female) with a mean age of 45±20.4 years (range, 19-77 years) who underwent minimally invasive lumbopelvic fixation (lpf) were included in the study.Surgery was performed using viper instrumentation (depuy synthes spine, inc, raynham, ma, usa) combined with other competitor devices for associated pelvic ring injuries.The average follow-up duration for the entire cohort was 18.8±16.8 months (range, 0.4¿64 months).The following complications were reported as follows: patient 11: a (b)(6) year-old male patient underwent revision instrumentation on postoperative day 3 for a malpositioned l5 pedicle screw seen on the postoperative computed tomographic scan.The screw was revised; however, the results of the neurologic examination were grossly unchanged at the time of discharge and the patient was still wearing an ankle-foot orthosis 1 year later.Patient 7: a (b)(6) year-old female patient presented 10 months later with pain at the lpf instrumentation site and had wound infection requiring antibiotic treatment and return to the or for irrigation and debridement with removal of instrumentation.Patient 12: a (b)(6) year-old male patient underwent serial irrigation and debridement procedures for his anterior and lateral wounds from traditional fixation beginning 4 days after undergoing minimally invasive lpf and subsequent removal of instrumentation on postoperative day 14 for persistent infections involving his pelvic wounds.Wound cultures grew vancomycin-resistant enterococcus and (b)(6), which were treated with a combination of multiregimen antibiotics, including vancomycin, ciprofloxacin, ampicillin/sulbactam, meropenem, metronidazole, and trimethoprim/sulfamethoxazole.Patient 8: a (b)(6) year-old female patient who had morel-lavallée lesions over the sacrum, underwent removal of instrumentation (roi).Patient 3: a (b)(6) year-old male patient underwent elective removal of instrumentation.Patient 13: a (b)(6) year-old female patient underwent elective removal of instrumentation.Patient 19: a (b)(6) year-old female patient underwent elective removal of instrumentation.Patient 20: a (b)(6) year-old female patient underwent elective removal of instrumentation.Patient 22: a (b)(6) year-old female patient underwent elective removal of instrumentation.Patient 24: a (b)(6) year-old female patient underwent elective removal of instrumentation.Patient 15: a (b)(6) year-old male patient had returned on postoperative day 13 with a fever, altered mental status, and abdominal pain.The patient experienced a seizure and was subsequently intubated.Blood cultures were positive for escherichia coli, and cerebral spinal fluid cultures were negative.Computed tomography showed intra-abdominal free fluid and bowel wall thickening.The patient died as a result of high output cardiac failure, which resulted from sepsis on postoperative day 14, and this was not thought to be related to the minimally invasive lpf procedure.Of the 7 patients who underwent roi, only 1 had a fusion procedure.An unknown number of patients had an average estimated blood loss was 180±143 ml (range, 25¿500 ml).16 patients required transfusions (2.1±1.3 units packed red blood cells; range, 0¿6 units).This report is for an unknown depuy spine viper mono/polyaxial screws.This is report 5 of 6 for (b)(4).

Manufacturer Narrative

Product complaint # pc-(b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product was not returned.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: UNK - CONSTRUCTS: VIPER
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 12455279
• MDR Text Key: 272131884
• Report Number: 1526439-2021-01947
• 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: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• 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: 11/01/2021
• 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