MAUDE Adverse Event Report: SYNTHES GMBH UNK - BIOMATERIAL - PREFORMED: CHRONOS: TRAUMA; POLYMETHYLMETHACRYLATE BONE CEMENT

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

Patient Problems Unspecified Infection (1930); Unspecified Musculoskeletal problem (4535)

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.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 biomaterial - preformed: chronos: trauma/unknown lot.Part and lot numbers are unknown; udi 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 finland as follows: this report is being filed after the review of the following journal article: stoor, p.Et al (2016), rapid prototyped patient specific guiding implants in critical mandibular reconstruction, journal of cranio-maxillo-facial surgery vol.45, pages 63-70 (finland).The aim of this study was to assess if a clinically usable patient specific mandibular implant with the right anatomic shape can be manufactured utilizing cad - cam technique.The second aim was to study if the implant could be designed in such a way that it guides without navigation the surgeon to place the implant in the operative theatre similarly to the cad design.During the study, a total of (15 patient specific implants or psis) 14 patients (10 male and 4 female) with a mean age of 63 years were included in the study.These patients suffered from squamous cell carcinoma ameloblastoma or drug induced osteonecrosis and had to undergo construction of the maxillofacial area.In surgery, the patient specific implant or psi was fixed with a 2.0 titanium screws (synthes).All psis were filled with beta-tricalciumphosphate (b-tcp) granules (chronos granules synthes, oberdorf, switzerland).The average follow-up for all patients was 33 months.The following complications were reported as follows: - 1 patient had major lack of the bone (substitute); - 2 patients with the implant were exposed, and; - 1 patient with air connection to the plate being suspected; - 1 patient had suspected with recurrence of abscess or tumur; - 2 patients with defect in plate fitting at follow up; - 5 patients died during the follow up; 3 patients died due to spreading of the tumor into to the scull.1 patient died due to bladder carcinoma, and 1 due to pulmonary carcinoma.- 1 patient had a perforation in the lingual mucosa due to the rp-implant being too high at that region.- 1 patient had a slight disturbance in the occlusion, which was corrected with dental ceramic inserts and on-lays.- 1 patient lost the anterior and lateral thigh microvascular flap during the first postoperative week due to venous difficulty.Re-reconstruction with radial forearm microvascular flap was uneventful.- 4 patients had perforation of the lingual mucosa leading to infection.3 of the 4 patients had removal of the psi due to infected bone substitute b-tcp; this was treated with a deep circumflex iliac artery composite microvascular flap (dcia).While 1 patient only the scaffold part of the psi had to be removed, and the inferior rigid plate part was left with uneventful healing.This report is for an unknown synthes titanium plate, and unknown synthes beta-tricalciumphosphate (b-tcp) granules (chronos, synthes).A copy of the literature article is being submitted with this medwatch.This report involves one unk - biomaterial - preformed: chronos: trauma.This is report 1 of 2 for pc-001553717.

• Brand Name: UNK - BIOMATERIAL - PREFORMED: CHRONOS: TRAUMA
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• 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: 18865150
• MDR Text Key: 337212399
• Report Number: 8030965-2024-03393
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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

• Date FDA Received: 03/08/2024
• 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: 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
• Treatment: UNK - SCREWS: MAXILLOFACIAL.
• Patient Outcome(s): Required Intervention