MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - SCREW/ROD CONSTRUCT ACCESSORIES: MOUNTAINEER OCT; SCREW, FIXATION, BONE

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

Patient Problems Hemorrhage/Bleeding (1888); Sepsis (2067); Urinary Tract Infection (2120); Unspecified Mental, Emotional or Behavioural Problem (4430)

Event Date 08/24/2021

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: issa, m.Et al (2021), morbidity and mortality in patients over 90 years of age following posterior stabilization for acute traumatic odontoid type ii fractures: a retrospective study with a mean follow-up of three years, journal of clinical medicine, vol.10 (3780), pages 1-11 (b)(6).This retrospective, single-center study based on a prospectively kept database was conducted to assess morbidity and mortality in patients over 90 years of age undergoing ct-guided posterior stabilization for unstable odontoid type ii fractures.Between january 2010 and december 2019, a total of 15 patients (2 male and 13 female; with median age of 91.4±2 years [range 90¿96 years]) who underwent posterior cervical fusion using a modified goel-harms technique were included.A polyaxial titanium alloy screw system (mountaineer oct system, depuysynthes, warsaw, in, usa) was used.The average follow-up (fu) was 36 months (range 9¿72 months).Another set of patients, a total of 72 patients between 65 and 89 years old (mean age 78.8 years, 55.4% female) were selected as reference group to compare complication rates within different age groups.The following complications were reported as follows: patients = 90 years old: 5 patients died during the follow-up period.Two patients died 12 and 35 months after surgery for unknown reasons.One patient died 56 months after surgery due to acute decompensated heart failure.One patient died 21 months after surgery of hepatocellular carcinoma that was diagnosed at a later stage.The fifth patient died 9 months after surgery as a result of a heart attack.All the deceased patients had at least five comorbidities.The average time to death was 26.6 months (range 9¿56 months).1 c2 screw was penetrating the transverse foramen with a close relationship to the vertebral artery.However, this patient remained without any symptoms.In 2 patients, blood transfusion was necessary due to a dual antiplatelet therapy.1 patient developed a pneumonic sepsis caused by inferior lobe pneumonia after surgery and fully recovered within several weeks.27% of cases had minor complications which could be treated successfully using medication.Of these, 2 patients developed urinary tract infection, 1 patient had a delirium, and 1 patient had epistaxis.A copy of the literature article is being submitted with this medwatch.This report is for an unk - screw/rod construct accessory: mountaineer oct.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.This report is for an unknown device/unknown lot.Part and lot numbers are unknown; udi number is unknown.Device avilable for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Device evaluated by mfr and manufacture date: 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.

• Brand Name: UNK - SCREW/ROD CONSTRUCT ACCESSORIES: MOUNTAINEER OCT
• Type of Device: SCREW, FIXATION, BONE
• 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: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 15294168
• MDR Text Key: 298600927
• Report Number: 1526439-2022-01464
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2022
• Initial Date FDA Received: 08/25/2022
• 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): Other