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

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

Patient Problems Cerebrospinal Fluid Leakage (1772); Eye Injury (1845); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Brand name, common device name, procode, mfr, lot #, part #, udi #, 510k: this report is for an unknown cmf plate/unknown lot.Part and lot numbers are unknown; udi number is unknown.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Device evaluated by mfr, manufacture date: 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: hariri, f.Et al.(2014), monobloc le fort iii distraction osteogenesis for correction of severe fronto-orbital and midface hypoplasia in pediatric crouzon syndrome, the cleft palate-craniofacial journal, vol.53(1), pages 118-125 (malaysia).The objective of this study is to evaluate two patients with pediatric crouzon syndrome treated by distraction osteogenesis (do) using a combination of external and internal distraction devices and to review some critical issues regarding the application of do in craniofacial surgery.This study presents a 2 cases of a (b)(6) boy and a (b)(6) girl, who were both diagnosed with crouzon syndrome.Both patients presented with severe orbital proptosis and obstructive sleep apnea secondary to a severely hypoplastic midface.Both patients had undergone multiple surgical procedures involving conventional fronto-orbital advancement to decompress the cranial cavity and salvage the function of the eyes and had undergone tracheostomy to bypass the obstructed upper airway.Patient 1 ((b)(6) male) underwent tarsorrhaphy on both eyes after birth but eventually developed right eye blindness secondary to persistent corneal abrasion damage resulting from severe exorbitism.Both patients successfully underwent the monobloc le fort iii do via a combination of coronal and intraoral approaches.To ensure stability and optimum segmental advancement, both an external midface distractor and 2 internal craniomaxillofacial distractors (synthes, oberdorf, switzerland) were used.The external midface distractor consisted of 2 zygomatic plates with percutaneous pins, placed bilaterally at the glabella region, and another 2 plates in the maxilla, placed bilaterally just lateral to the piriform rim.Patient 1 was noted to have a cerebrospinal fluid (csf) leat at 2 weeks postoperatively.The condition was treated conservatively with close monitoring, antibiotics, and reduction of the distraction rate.He also developed right eye exodeviation with limited abduction, which was noted when advancement reached 23 mm.An urgent computed tomography scan showed that there was impingement of the lateral rectus muscle in the globe region from the distracted segment.A surgical procedure to relieve the impingement was performed, and eye function had returned to normal 2 weeks after the procedure.Both patients later underwent 2 additional procedures.The first procedure was for the removal of the external frame and wound revision in the temporal region.The second surgery was for the removal of the internal distractors and plates.Follow-up at 18 months after distraction showed successful outcomes, as evidence by the acceptable facial profile.This is report 7 of 8 for (b)(4).This is for an unknown synthes cmf plate for (b)(6).

• Brand Name: UNK - PLATES: CMF
• 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: 8798628
• MDR Text Key: 151314000
• Report Number: 8030965-2019-66297
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• 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
• Patient Age: 3 YR