MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - PSI IMPLANTS; PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE

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

Patient Problem Pocket Erosion (2013)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown patient-specific implant 0.6 mm titanium mesh/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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: zhang w-b, et al.(2019), outcomes of zygomatic complex reconstruction with patient-specific titanium mesh using computer-assisted techniques, j oral maxillofac surg, page 1-13, (china).The aim of this retrospective study was to evaluate the clinical procedure and outcomes of zygomatic complex reconstruction with patient-specific titanium mesh using a computer-assisted technique.From april 2015 through april 2017, 9 patients who underwent midface reconstruction with patient-specific titanium mesh fabricated using a computer-assisted technique were included in the study.There were 4 men and 5 women with a mean age of 43.7 years (range, 16 to 70 years).The patients underwent tumor resection with maxillectomy that included the zygomatic complex that was performed according to the virtual plan.The tumor resection and maxillectomy were simulated virtually using unknown proplan cmf (materalise, leuven, belgium) according to clinical and 3d radiographic findings.All patients were implanted with pre-bent unknown synthes patient-specific implant 0.6 mm titanium mesh to rehabilitate the contour of the zygomatic complex.The mesh was fixed to the residual bone with 4- to 5-mm microscrews.Surgical defects were reconstructed with bony or soft tissue free flaps and the dead space deep to the mesh was filled by subcutaneous tissue or the muscle layer of the flap.The surface of the mesh also was covered by the flap tissue, particularly in the nasal and inner canthus area and the lateral region of the zygoma.All patients were followed for at least 12 months.The mean duration for follow-up was 27.3 months (range, 15 to 39 months).Complications were reported as follows: patient 3, a (b)(6) year-old female had titanium mesh exposure after radiotherapy in the lateral region on the zygoma; a secondary surgery was performed with a local advancement flap to cover the exposed titanium mesh.Patient 7, a (b)(6) year-old female developed local recurrence of osteosarcoma with distant metastasis and died of disease during the follow-up period.This patient also had postoperative diplopia.This is report 1 of 3 for (b)(4).This report is for the unknown synthes patient-specific implant 0.6 mm titanium mesh and unknown synthes microscrews.

• Brand Name: UNK - PSI IMPLANTS
• Type of Device: PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10065532
• MDR Text Key: 195094200
• Report Number: 8030965-2020-03556
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2020
• 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: 05/05/2020
• 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: 45 YR