MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - CONSTRUCTS: PLATE/SCREWS; PLATE, FIXATION, BONE

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

Patient Problems Injury (2348); Non-union Bone Fracture (2369); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown long philos plate (lpp) constructs/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.(b)(4).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.

Event Description

This report is being filed after the review of the following journal article: jeong j.,et al (2019) narrow locking compression plate vs long philos plate for minimally invasive plate osteosynthesis of spiral humerus shaft fractures, bmc musculoskeletal disorders volume 20, pages 381-388(korea, south).This study aims to compare clinical and radiological outcomes of patients using nlcp with those of patients using lpp for spiral humerus shaft fractures with or without metaphyseal extension.Between march 2009 and march 2017, 35 patients for whom mipo technique was performed for spiral humerus shaft fractures with or without distal or proximal metaphyseal fracture extension were enrolled.Minimal invasive plate osteosynthesis (mipo) was done using nlcp or long philos plate (lpp, ao, switzerland, davos) 18 patients(7 males, 11 females) age 62.7 underwent mipo with 4.5mm narrow lcp: nlcp (group i).And then, 17 patients (4 males, 13 females) age 61.2 years underwent mipo with long philos plate: lpp (group ii).Mean follow-up was 16 months (range, 8 to 60 months).The following complications were reported as follows: radiologic findings of both groups showed complete bony union except 2 patients.And those 2 patients achieved bony union after revision surgery.2 patient who had failed with initial surgery using lpp achieved complete union with revision surgery using nlcp and bone graft.Postoperative transient radial nerve injury was found in 3 patients (2 patients in nlcp group and 1 patient in lpp group) due to traction or retractors.These symptoms were completely recovered within 3 months.Fig.4 a case of a (b)(6) year old female patient anteroposterior and lateral x-ray showing the metal failure of spiral (spiral wedge type, ao classification: b1) humerus shaft fracture.Patient underwent revision using open approach, narrow locking compression plate was used with bone graft.(after 2 metal failure, surgeon tried to insert additional positional screw in the middle part of plate of the unstable fractures (figs.4, 5).In the earlier period of lpp group, no additional locking or compression screw at the middle part of the lpp plate developed two metal failure.Figure 5 a case of an 85 year-old female patient treated with lpp.In the midportion of the long philos plate, additional locking or compression screws were inserted through several small incisions for further rigid fixation long humeral philos plate could fix this complex humeral shaft fracture adequately.(after 2 metal failure, surgeon tried to insert additional positional screw in the middle part of plate of the unstable fractures (figs.4, 5).This report is for an unknown synthes long philos plate (lpp) constructs.It captures the reported events of 2 patients who achieved bony union after revision surgery, 2 patient who had failed with initial surgery using lpp achieved complete union with revision surgery using nlcp and bone graft, and postoperative transient radial nerve injury was found in 3 patients (2 patients in nlcp group and 1 patient in lpp group) due to traction or retractors.This is report 2 of 8 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PLATE/SCREWS
• 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: 10792326
• MDR Text Key: 214793003
• Report Number: 8030965-2020-08613
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• 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: 10/09/2020
• 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