MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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

Patient Problems Pain (1994); Loss of Range of Motion (2032); Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown viper system/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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: spiegl, u.J.Et al (2021), midterm outcome after posterior stabilization of unstable midthoracic spine fractures in the elderly, bmc musculoskeletal disorders, vol.22 (188), pages 1-10 (germany).The aim of this retrospective study is to evaluate the clinical and radiographic midterm results of posterior stabilization for the treatment of unstable fractures of the midthoracic spine in patients aged 65 years or older.Between january 2010 to december 2017, a total of 59 patients (49% male and 51% female) with an average age of 76.9 years (range 65 to 89 years) were included in the study.Posterior stabilization was done with cement-augmented pedicle screws (matrix, fa.Depuysynthes; viper, fa.Depuysynthes; competitor devices).Clinical and radiological follow-up was performed after 2, 6, 12 weeks, and 1 year after surgery.All patients were followed for at least 18 months after initial surgery.The average follow-up was 59.9 months (median: 56.6 months; range: 18¿111 months).The following complications were reported as follows: 21 patients (mean age at the time of surgery: 79.4 years) died during the follow-up period.One of those patients died during postoperative hospital stay from a pulmonary embolism.Unknown number of patients had a mean radiologic loss of reduction of 5.1° (range: 1°¿ 11°).3 patients had wound healing disorders.1 patient had mild pulmonary embolism.5 patients underwent revision surgeries consisting of extension of the posterior stabilization in 3 patients because of adjacent fractures, removal of the implant in 1 patient due to implant-related complains and soft tissue revision due to a wound healing disorder in 1 patient.A total of 12 sequential vertebral fractures were seen during the follow-up period.14 patients (41.1%) had a minor disability, 17.6% a moderate disability, 32.3% a severe disability, and 3 patients (8.8%) crippling back pain.A (b)(6) year-old female patient had low pain levels without any pain medication (vas: 2) at latest follow-up after 26 months.In a (b)(6) year-old female patient, an atraumatic subsequent fracture of the 3rd lumbar vertebral body occurred at the further course.At the latest follow-up after 69 months, the patient complained of permanent relevant pain (vas: 6), moderate limitations (odi: 45), and mild reduction loss as well as consolidated fracture 3rd lumbar body.This report is for an unknown depuy spine viper construct.It captures reported case of a (b)(6) year-old female patient who complained of permanent relevant pain (vas: 6), moderate limitations (odi: 45), and mild reduction loss as well as consolidated fracture 3rd lumbar body.This is report 1 of 2 for (b)(4).This is a related complaint of (b)4) (which involves synthes matrix).

• Brand Name: UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES
• 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 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12071443
• MDR Text Key: 266298061
• Report Number: 1526439-2021-01309
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• 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: 06/02/2021
• 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
• Patient Age: 68 YR