MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - PLATES: MATRIXMIDFACE; PLATE,FIXATION,BONE

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

Patient Problem Visual Impairment (2138)

Event Type  Injury  

Manufacturer Narrative

Various patient involved.Implantation date unknown.This report is for an unk - plates: matrixmidface /unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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

Device report from synthes reports an event in singapore as follows: this report is being filed after the review of the following journal article: seen s, et al.(2018), permanent versus bioresorbable implants in orbital floor blowout fractures, ophthal plast reconstr surg, volume 34, page 536-543, (singapore).The purpose of this study is to compare the outcomes of bioresorbable and permanent implants in the reconstruction of isolated orbital floor blowout fractures.From january 2005 to december 2014, 88 patients who had isolated orbital floor blowout fracture repair were included in the study.There were 71 male patients and 17 female patients with a mean age of 34.3+/-15.6 years (range, 5-72 years).48 patients were implanted with bioresorbable implant in which 31 patients were implanted with an unknown synthes rapidsorb implants, 10 patients were implanted with an unknown synthes polymax implant, and the rest of the patients were implanted with 2 other competitors¿ devices.Meanwhile, 40 patients were implanted with permanent implants in which 19 patients had prefabricated anatomical titanium implants (unknown synthes matrix midface titanium preformed orbital plate, unknown synthes matrix midface titanium orbital mesh plate, and unknown synthes titanium orbital anatomic floor plate), 2 patients were implanted with an unknown synthes synpor titanium orbital floor mesh plate, and the rest of the patients were implanted with a competitor¿s devices.Optic nerve function of all patients was monitored postoperatively.Patients were reviewed at the following intervals 1 day, 1 week, 1 month, 3 months, 6 months, 1 year, and 15¿24 months.Complications were reported as follows: (resorbable implant).17 patients had diplopia at 1 month postoperatively.8 patients had diplopia at 6 months postoperatively.4 patients had diplopia at 1 year postoperatively.12 patients had ocular motility limitation at 1 month postoperatively.5 patients had ocular motility limitation at 6 months postoperatively.3 patients had ocular motility limitation at 1 year postoperatively.1 patient had ocular motility limitation at 1.5 years postoperatively.1 patient had enophthalmos at 1 month and 6 months postoperatively.1 patient reported upgaze restriction at postoperative month 6 follow-up review.Ct scan revealed a mispositioned implant that was too small for the fracture (fig.2b).Patient was treated conservatively and upgazed restriction resolved by 1 year postoperatively.(rapidsorb).(permanent implants).12 patients had diplopia at 1 month postoperatively.3 patients had diplopia at 6 months postoperatively.2 patients had diplopia (within 30 degrees of primary gaze) at 1 and 1.5 years postoperatively.15 patients had ocular motility limitation at 1 month postoperatively.6 patients had ocular motility limitation at 6 months postoperatively.2 patients had ocular motility limitation at 1 year postoperatively.1 patient had ocular motility limitation at 1.5 years postoperatively.2 patients had enophthalmos at 1 month postoperatively.1 patient had enophthalmos at 6 months postoperatively.1 patient had secondary orbital hemorrhage resulting in raised intraocular pressure (iop) and orbital compartment syndrome.The impervious nature of porous polyethylene resulted in the formation of a collection of blood.The patient¿s iop returned to normal following medical treatment with intravenous acetazolamide, topical brimonidine, and timolol.(synpor) 1 patient had reoperation due to malposition of titanium implant that was noted on the ct scan at postoperative day 1 (fig.3b).The medial aspect of the implant was inferior to the orbital wall.(matrix midface titanium orbital mesh plate).This report is for the unknown synthes rapidsorb implants, unknown synthes polymax implant, unknown synthes matrix midface titanium preformed orbital plate, unknown synthes matrix midface titanium orbital mesh plate, unknown synthes titanium orbital anatomic floor plate and unknown synthes synpor titanium orbital floor mesh plate.This is report 5 of 8 for (b)(4).

• Brand Name: UNK - PLATES: MATRIXMIDFACE
• Type of Device: PLATE,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 19380 ; 6103142063
• MDR Report Key: 10026931
• MDR Text Key: 194492730
• Report Number: 8030965-2020-03313
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 04/21/2020

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention