MAUDE Adverse Event Report: SYNTHES GMBH UNK - BIOMATERIAL - PREFORMED: CHRONOS: TRAUMA; FILLER, BONE VOID, CALCIUM COMPOUND

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Migration (4003)

Patient Problems Stroke/CVA (1770); Pneumonia (2011); Urinary Tract Infection (2120); Ulcer (2274); Post Operative Wound Infection (2446); Insufficient Information (4580)

Event Date 01/01/2023

Event Type  Injury  

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.D1, d2, d3, d4, g4-510k: this report is for an unknown bio - preformed: chronos: tr/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: 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

Device report from synthes reports an event in taiwan as follows: this report is being filed after the review of the following journal article: choua, p-s.Et al (2023), posterior instrumentation for osteoporotic fractures in the thoracic or lumbar spine: cement augmented pedicle screws vs hybrid constructs, journal of chinese medical association vol.86, pages 431-439 (taiwan).The goal of this retrospective cohort study was to compare the surgical outcomes and surgery, patient, and implant-related complications between the cps and hc techniques for osteoporotic vertebral fractures of the thoracic or lumbar spine.This retrospective cohort study included 99 consecutive patients with osteoporotic vertebral fractures who were treated surgically from january 2011 to december 2015.15 patients were excluded from the study: 8 lost to follow-up (they did not complete the latest plain radiograph of spine), 2 died of unrelated medical conditions, 3 had degenerative scoliosis, and 2 had t scores greater than -2.5 5 (who criterion for osteoporosis).A total of 84 patients (22 male and 62 female) and a mean age of 77.75 years were eventually included in the study.The patients were divided into two groups: the cps group (cement-augmented polyaxial cannulated pedicle screws, smartlock omega) with 43 patients (13 male and 30 female) and a mean age of 77.3 years; and the hc group (hybrid constructs, a combination of hooks and pedicle screws, smartlock omega) with 41 patients (9 male and 32 female) and a mean age of 78.2 years.Bone grafting was accomplished using a mixture of autogenous bone graft, which was harvested from decompressed laminae and the spinous processes, and bone substitute (synthetic ¿-tricalcium phosphate, chronos, depuy synthes, pa, usa).Every patient was followed up with serial supine anteroposterior and lateral radiographs every 6 weeks postoperatively for 3 months; at 3, 6, and 12 months; and then annually for 5 years.The following complications were reported as follows: cps group 2 patients had wound infection.1 patient had implant failure - had back-out of the four cephalad cemented screws, patient refused implant removal due to his medical condition.Cement-related complications.134 patients had screw augmentation (linear or spotted pattern leakage of screws) 4 patients had pneumonia.2 patients had urinary tract infection.1 patient had stroke (transient ischemia attack).1 patient had peptic ulcer.Hc group 2 patients had wound infection.1 patient had implant failure - had back-out of the distal hook screw claw construct.Implant removal was performed due to skin impingement.3 patients had pneumonia.2 patients had urinary tract infection.This report is for an unknown synthes chronos.A copy of the literature article is being submitted with this medwatch.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - BIOMATERIAL - PREFORMED: CHRONOS: TRAUMA
• Type of Device: FILLER, BONE VOID, CALCIUM COMPOUND
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18748358
• MDR Text Key: 335934920
• Report Number: 8030965-2024-02698
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 02/21/2024
• 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