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 Unspecified Infection (1930); Nerve Damage (1979)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown dcp, lcp 4.5/3.5 narrow, philos and philos long (plate/screw construct)/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.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: chen d., liu, j., li s., et al (2019) outcome assessment of z-shaped osteotomy in the management of humeral shaft nonunion secondary to failed plate osteosynthesis,current medical science volume 39(3), pages 426-430 (china).This retrospective study aims to introduced a new way of osteotomy (z-shaped) that can increase bone contact areas and is easy to perform.Between 2010 and 2014, a total of 24 patients (10 males and 14 females) with their average age of 52.21±11.56 years who had humeral nonunion following implant failure were included in the study.Dcp (n=5) or lcp (n=19) was used for initial plate osteosynthesis.Lcp 4.5/3.5 narrow (depuy synthes) or philos or philos long¿ (depuy synthes, usa) was used in revision surgery.Patients were followed up for a minimum of 24 months (26.83±4.33 months).The following complications were reported as follows: all the patients were diagnosed with atrophy nonunions following implant failure.(initial surgery) radial palsy occurred postoperatively in one patient and was completely recovered in 4¿6 months without any treatment, and superficial wound infection was healed in one patient after postoperative debridement and antibiotic therapy, and no deep infections occurred.(after revision) a case of a 32-year-old female with type 12-a3 transverse humeral fracture; b: the initial surgical treatment using lcp was failed 5 months later.Underwent z-shaped osteotomy and fixation with 3.5 mm lcp.Osteotomy.Achieved clinical union following revision surgery(fig.2)representative case of plate breakage.A case of a 65-year-old female with type 12-a1 spiral humeral shaft fracture; b: 18 months after initial fixation, the screws were ¿backing out¿.Underwent osteosynthesis using philos long¿ combined with auto-iliac bone grafting and z-shaped osteotomy.Achieved clinical union following revision surgery(fig 3) representative case of internal fixation failure.A case of a 28-year-old male with type 12-b1 comminuted proximal humeral fracture, 6 months later, initial implant was failed.The patient then received external fixation to control infection.The intramedullary canal was reconstructed using z-shaped osteotomy and osteosynthesis with philos and auto-iliac bone graft.Osteotomy.Achieved clinical union following revision surgery(fig 4) representative case of infectious nonunion.This is report 5 of 10 for (b)(4).This report is for an unknown synthes dcp, lcp 4.5/3.5 narrow, philos and philos long (plate/screw construct).

• 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: 10529349
• MDR Text Key: 213718448
• Report Number: 8030965-2020-06933
• 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: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• 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: 08/18/2020
• 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