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 Edema (1820); Eye Injury (1845); Visual Impairment (2138); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown cmf 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.(b)(4): additional medical/surgical intervention required and eye movement disorder.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: sung woo park, jong woo choi, kyung s.Koh, and tae suk oh (2015), mirror-imaged rapid prototype skull model and pre-molded synthetic scaffold to achieve optimal orbital cavity reconstruction, journal of oral and maxillofacial surgery vol.73(8), pages 1540-1553 (korea, south).The retrospective study that evaluates the mirror-imaged rapid prototype skull model and a pre-molded synthetic scaffold for traumatic orbital wall reconstruction.Between january 2012 to april 2014, a total of 127 patients (83 males and 44 females) with a mean age of 35 years (range, 11 to 87 years) were included in the study.The 57 patients were completed using a porous polyethylene plate (synthes) and 45 patients used a competitor¿s device for orbital reconstruction.In addition, 23 cases were found to have no true orbital wall defect and therefore underwent open reduction of the facial buttress or soft tissue augmentation for post-traumatic deformity.However, 2 cases showed extensive orbital wall defects and loss of the orbital rim framework, for which conventional ready-to-wear synthetic material was not sufficient.For these patients, titanium mesh (synthes) was used and fixed onto the intact facial buttress.After exposure of orbital wall defects, pre-molded synthetic scaffolds were placed on the defect and further fixated with 4-mm matrix midface screws (synthes) when needed.The mean duration of follow-up was 14 months.The article did not specify which of the devices were being used to capture the following complications: 10 patients had mild enophthalmos with less than 2-mm difference were reported, but no further revisionary procedures were performed.2 patients had persistent diplopia and underwent reoperation.1 patient had severe ocular rectus muscle edema that, with proper coverage with a synthetic scaffold, resolved spontaneously 3 weeks after the revisionary procedure.4 patients underwent a secondary touchup procedure to contour the overlying soft tissue (2 lower blepharoplasties, 1 flap debulking, and 1 ectropion correction).1 patient, the synthetic scaffold was too large for the defect; therefore, the scaffold was trimmed and reinserted over the defect and the diplopia was resolved after the revisionary procedure.This report is for unknown cmf screws.This report is 5 of 5 for complaint (b)(4).It captures the reported events of mild enophthalmos, persistent diplopia, severe ocular rectus muscle edema.

• 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: 8906320
• MDR Text Key: 154741889
• Report Number: 8030965-2019-67419
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• 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: 07/23/2019
• 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