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

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

Patient Problem Wound Dehiscence (1154)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unk - resorbable implants: plates/unknown lot.Part and lot numbers are unknown; udi 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 as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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.

Event Description

Device report from synthes reports an event in japan as follows: this report is being filed after the review of the following journal article: matsuda y, et al.(2021), complications of poly-l-lactic acid and polyglycolic acid (plla/pga) osteosynthesis systems for maxillofacial surgery: a retrospective clinical investigation, polymers, volume 13, 889, pages 1-11, (japan).The purpose of this retrospective study was to clinically evaluate and examine the incidence of postoperative complications while comparing the two plla/pga copolymer bioresorbable plate systems (rapidsorb® and lactosorb®) in maxillofacial surgical applications.From 2012 to 2019, 148 patients who underwent maxillofacial surgeries of the midfacial region, namely, midfacial fracture/trauma or maxillary osteotomy for dentofacial deformity surgery using the bioresorbable materials of plla/pga copolymer plate systems.There were 81 males and 67 females.A total of 61 patients were implanted with the unknown synthes rapidsorb plate while 87 patients were implanted with a competitor¿s acid copolymer plate.The plates were placed at the pyriform aperture (127 plates), periorbita (79 plates), orbital floor (3 plates), alveolar bone (12 plates), maxillary sinus anterior wall (14 plates), frontal bone (2 plates), infrazygomatic crest (135 plates), and zygomatic arch (14 plates).The total number of plates was 386.The patients had more than six months of regular clinical and radiographic postoperative follow-ups at one week and 1, 3, 6, and 12 months.They were followed for up to 12 months when osteosynthesis was insufficient for six months.The article did not specify which patients were implanted with the synthes device.Thus, complications will be reported: 11 patients had plate exposure.4 patients had infection.1 patient had plate breakage.This report is for the unknown synthes rapidsorb plate and screws.This report is for (1) unk - resorbable implants: plates this report is 2 of 3 for (b)(4).

• Brand Name: UNK - RESORBABLE IMPLANTS: PLATES
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11957354
• MDR Text Key: 254858813
• Report Number: 8030965-2021-04656
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• 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: 05/13/2021
• 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