MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS: CMF; SCREW, FIXATION, BONE

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

Patient Problems Visual Impairment (2138); Hypoesthesia (2352)

Event Date 07/01/2019

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown screws/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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: kim m., et al (2019) clinical application of a specific simulation software for 3-dimensional orbital volume modeling for orbital wall reconstruction, annals of plastic surgery , volume 83, number 1, pages 48-54 (korea, south) doi: 10.1097/sap.0000000000001830.This retrospective study aims to clinically apply a newly developed 3d preoperative planning software, demonstrate its effectiveness by measuring orbital volume change, and share our experiences.Between december 2015 and february 2018, a total of 56 patients (47 males and 9 females) with a mean age of 40.30 ± 0.37 years who underwent orbital wall reconstruction due to medial and/or inferior orbital wall fracture were included in the study.In the intraoperative procedure, a 0.8-mm-thickness porous polyethylene-coated titanium mesh (synpor; synthes, inc, west chester, pennsylvania) was used to cover the bony defect.Follow-up period was 4.54 ± 5.33 months.The following complications were reported as follows: -postoperative physical examination revealed only 1 case of extraocular muscle limitation and 3 cases of enophthalmos.-12 cases of diplopia.-16 cases of hypoesthesia.This report is for an unknown synthes cmf screws.This is report 2 of 2 for complaint (b)(4).

• Brand Name: UNK - SCREWS: CMF
• Type of Device: SCREW, FIXATION, BONE
• 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: 10026853
• MDR Text Key: 194616610
• Report Number: 8030965-2020-03306
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• 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: 04/22/2020
• 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