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); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown constructs: plate/screws /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.(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 synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: puri a., gulia a., jambhekar n., laskar s., (2012) the outcome of the treatment of diaphyseal primary bone sarcoma by resection, irradiation and re-implantation of the host bone, the journal of bone and joint surgery, volume 94-b, pages 982¿988 (india)doi:10.1302/0301-620x.94b7.28916.This study aims to analyse the results of all cases of primary extremity diaphyseal sarcomas reconstructed with extracorporeal radiation having a minimum follow-up of 24 months.Between march 2005 and september 2009, 32 patients (24 males , 8 females) with a mean age of 15 years (2 to 35) with diaphyseal sarcomas underwent en bloc resection with preservation of the adjoining joints and re-implantation of the tumour bone sterilised by extracorporeal radiation.Fixation was also done with various types of plates in 29 cases (standard dynamic compression plates (n = 8),reconstruction plates (n = 2) ,dynamic condylar screw plates (n = 6),locking compression plates (n = 9) custom-made plates (n = 4), and intramedullary nails in the remaining three patients.The mean follow-up was 34 months (12 to 74).A total of 31 patients were available at a mean follow-up of 34 months (12 to 74).The following complications were reported as follows: death: a case of a (b)(6) year old male (patient no.2) with ewing's sarcoma treated with dcp died of the disease at the time of last review.A case of a (b)(6) year old female (patient no.3) with ewing's sarcoma treated with dcs died of the disease at the time of last review.A case of a (b)(6) year old male (patient no.4) with ewing's sarcoma treated with dcp died of the disease at the time of last review.A case of a (b)(6) year old female (patient no.11) with ewing's sarcoma treated with dcs died of the disease at the time of last review.A case of a (b)(6) year old male (patient no.14) with osteogenic sarcoma treated with dcs died of the disease at the time of last review.A case of a (b)(6) year old male (patient no.24 ) with osteogenic sarcoma treated with lcp died of the disease at the time of last review.Died before union.A case of a (b)(6) year old female (patient no.1) treated with dcs developed an infection and the graft was removed and the defect reconstructed using an antibiotic impregnated cement spacer.A case of a (b)(6) year old male (patient no.5) treated with dcp had synchronous local and distant recurrence.All were associated with disseminated disease and the recurrences were in soft tissue remote from the irradiated graft.A case of a (b)(6) year old male (patient no.6) treated with dcs developed an infection and the graft was removed.Patient had flail limb.A case of a (b)(6) year old male (patient no.10) treated with dcp developed post-operative skin necrosis requiring a flap cover.A case of a (b)(6) year old male (patient no.13) treated with dcs developed an infection after surgery for fracture after trauma and the graft was removed and the defect reconstructed using an antibiotic impregnated cement spacer.(one of the five cases/patients who had implant failure and nonunion was seen in at five diaphyseal osteotomy sites; they required open reduction and internal fixation with bone grafting.One of these patients subsequently developed an infection necessitating removal of the graft as described above (case 13).A case of a (b)(6) year old male (patient no.16) treated with lcp implant failure and nonunion was seen in five cases at five diaphyseal osteotomy sites; they required open reduction and internal fixation with bone grafting.A case of a (b)(6) year old female (patient no.19) treated with lcp had post-operative seromas formed and required drainage.Bone grafting was required for this patient.A case of a (b)(6) year old female(patient no.21) treated with dcp had vascular injury occurred due to the screws in the proximal tibia penetrating the vessel at operation and developed post-operative skin necrosis requiring a flap cover.A case of an (b)(6) year old male (patient no.22) treated with dcp developed post-operative skin necrosis requiring a flap cover.A case of an (b)(6) year old male (patient no.28) treated with lcp had vascular injury occurred at operation.A case of a (b)(6) year old male (patient no.29) treated with lcp had post-operative seromas formed and required drainage.Bone grafting procedures was required for this patient.(the same patient in fig 2: patient treated with extracorporeal irradiation and re-implantation with subsequent bone-grafting a) at eight months post-operatively showing delayed union, and b) at 18 months showing union.The arrows denote the osteotomy site.) a case of a (b)(6) year old patient female (patient no.32) treated with lcp had non-union and implant removal.The same patient with a late wound dehiscence and her ulnar implant was removed (case 32)she had a nonunion at the distal osteotomy but was not a candidate for further surgical intervention because of cardiac toxicity due to doxorubicin.This report is for an unknown synthes constructs: plate/screws.This is report 7 of 9 for (b)(4).A copy of the literature article is being submitted with this medwatch.

• 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: 10508243
• MDR Text Key: 206280668
• Report Number: 8030965-2020-06692
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• 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: 08/12/2020
• 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