MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; PLATE, FIXATION, BONE

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

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown synthes proximal humeral internal locking system (philos) long plate/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: osamura, n., ikeda, k.And matsubara, h.(2016), posterior approach using a proximal humeral internal locking system long plate for open fractures of the distal tibia: a report of three cases, journal of orthopaedic science, vol.21(4), pages 552-556 (japan).This study presents a proposal of a surgical procedure for open fractures of the distal tibia to prevent complications associated with traditional plate fixation, including mipo and report the use of proximal humeral internal locking system (philos) long plate fixation through posterior approach for three cases of open distal tibial fracture.A (b)(6) year-old man suffered an open segmental fracture of the right distal tibia and fibula in a motorcycle accident.Fracture fixation was performed; however, the fracture remained ununited and was complicated with methicillin-resistant staphylococcus aureus osteomyelitis.Surgical repair had to be done using unknown synthes philos long plate.Debridement was performed at the junction of the distal end of the fibula graft and the distal tibia 9 months after the fibula graft because of the recurrent osteomyelitis with purulence from the anterior aspect of the distal end of the fibula graft.The osteomyelitis resolved 2 months after the debridement and iliac bone grafting was then performed for nonunion of the distal docking site between the fibula graft and the tibia.27 months after fixation, the fibula graft was completely incorporated and the osteomyelitis had resolved.Another case of a (b)(6) year-old man suffered an open fracture of the left distal tibia and fibula with closed fracture of the contralateral diaphyseal tibia in a traffic accident.The open fracture was treated with a competitor¿s device.1 month after the device was removed and internal fixation using unknown synthes philos long plate was performed with iliac bone grafting, using a posterior approach.Because fracture site nonunion persisted 5 months after the philos plating, additional cancellous bone grafting and decortication were performed using an anterior approach, which resulted in complete union 3 months after the additional cancellous bone grafting.This report is for (b)(6) year-old man who had recurrent osteomyelitis with purulence and nonunion of the distal docking site.This report is for an unknown synthes proximal humeral internal locking system (philos) long plate.This is report 1 of 4 for (b)(4).

• 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: 8301997
• MDR Text Key: 134899315
• Report Number: 8030965-2019-60597
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/16/2019
• Initial Date FDA Received: 02/04/2019
• 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: 34 YR