MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - PLATES: 3.5 MM LCP EXTRA-ARTICULAR DISTAL HUMERUS PLATE; PLATE,FIXATION,BONE

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

Patient Problems Neuropathy (1983); Weakness (2145); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unk - plates: 3.5 mm lcp extra-articular distal humerus plate/unknown lot.Part and lot numbers are unknown; udi number is unknown.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 product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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 russia reports an event as follows: this report is being filed after the review of the following journal article: litvina ea, semenistyy aa (2020), a case report of extensive segmental defect of the humerus treated with masquelet technique, journal of shoulder and elbow surgery, volume 29, page 1368-1374, (russia).This article presents a clinical case report of a patient treated with an induced membrane technique for a 12-cm humerus shaft defect that resulted from unsuccessful treatment of primary simple transverse humerus fracture.The patient was a (b)(6) year old woman who sustained a simple transverse humeral shaft fracture as a result of a fall from a standing height.The patient was treated by intramedullary nailing.4 months later, the patient fell again and sustained another fracture below the nail while the first fracture was not completely healed.The patient underwent removal of nail and plate osteosynthesis.Postoperative radiographs demonstrated that the nail removal was complicated by additional fragmentation of the intermediate bone.On the follow-up visits at 2 and 4 months, there was no evidence of callus formation.The plate deformation was noted on postoperative films.Patient was recommended to use a splint to add stability and prevent further plate deformation and breakage.On later radiographs, there was still no evidence of fracture healing.On (b)(6) 2018, more than 1 year since the fracture and 6 months of elbow immobilization, there was evidence of atrophic nonunion and severe shoulder and elbow contracture.The reconstructive options that were considered: plan a, shortening; plan b, shortening þ autograft; plan c, masquelet procedure.During the first surgery, an unknown synthes 3.5 locking compression plate extra-articular distal humerus plate was initially fixed to the main fragments creating the 12-cm gap.The appropriate size of the required spacer was determined and a depuy cmw 1 gentamicin bone cement 40g spacer was created.The spacer was placed into the defect in such a way as to cover the bone ends with cement.The spacer was fixed to the plate by a cortical screw.There was no neurologic deficit after the surgery.The wound had healed uneventfully.The patient was recommended to use the arm as tolerated and come for the second stage in 4 weeks.At week 5, the patient underwent a second surgery.An unknown synthes reamer-irrigator-aspirator system was used for bone graft harvesting.A 50 ml of autologous bone was collected which was pressed in a syringe and mixed with granulated unknown synthes chronos bone void filler.The spacer was removed.The autologous bone graft mixed with b-tcp granules was placed into the chamber created.Postoperative radial nerve neuropathy developed and resolved spontaneously within 3 weeks.Resorption of proximal 2 cm of the transplant was noted on follow-up radiographs after 6 and 12 weeks.This problem was attributed to the lack of proper spacer preparation during the stage as a result of scar tissue formation in between the spacer and proximal bone fragment.The patient then underwent a third surgery where the scar tissue was excised, and the defect was filled with a corticocancellous autograft taken from the ipsilateral iliac spine.Intraoperatively, consolidation of the remaining part of the autograft was noted.The patient was placed in a sling for 6 weeks.The wound healed uneventfully.Complete consolidation of the graft was observed on follow-up visits.The patient achieved a good function of elbow and shoulder joints and a complete weight-bearing function of the arm with a mild loss of triceps strength.This report is for the unknown synthes 3.5 locking compression plate extra-articular distal humerus plate, unknown synthes screws and unknown synthes chronos bone void filler.This is report 2 of 3 for (b)(4).

• Brand Name: UNK - PLATES: 3.5 MM LCP EXTRA-ARTICULAR DISTAL HUMERUS PLATE
• 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: 10567869
• MDR Text Key: 208325785
• Report Number: 8030965-2020-07302
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: RS
• 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: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• 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: 08/28/2020
• 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
• Patient Age: 46 YR