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

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

Patient Problem Visual Impairment (2138)

Event Date 02/03/2019

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown resorbable plates/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: pan, hui et al (2019), bioresorbable material in secondary orbital reconstruction surgery, journal of opthalmology, volume 2019, article id 8715314, pages 1-7 (china).The aim of this retrospective study is to validate the potential of bioresorbable implantation in secondary revisional reconstruction after inadequate primary orbital fracture repair, with the assessment of pre- and postoperative clinical characteristics and computed tomography image findings.Between july 2010 to june 2017, a total of 16 patients (9 males and 7 females) were included in the study.All patients were reconstructed using a square plate of 85:15 poly(l-lactide-co-glycolide) (rapidsorb, synthes, oberdorf, switzerland) by a transconjunctival approach after unsatisfactory primary repair.Mean age at the time of secondary surgery was 37 years, with a range of 14 to 67 years.Mean follow-up was 18.4 ± 5.9 months.The following complications were reported as follows: 1 patient had persistent diplopia on the down gaze as before.This report is for an unknown synthes resorbable plates.This is report 1 of 2 for (b)(4).

• Brand Name: UNK - RESORBABLE IMPLANTS: PLATES
• 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, PA 19380 ; 6103142063
• MDR Report Key: 8790899
• MDR Text Key: 151114339
• Report Number: 8030965-2019-66243
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• 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: 06/19/2019
• 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