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 liss construct/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: peschiera v., et al (2018) predicting the failure in distal femur fractures , injury, int.J.Care injured volume 49 s3, pages s2¿s7 (italy).This study aims to identify factors that can predict nonunion and give technical principles for correction.From october 2007 to december 2017, 86 distal femoral fractures (perimplant and pathological fracture where excluded by the initial 116 cases), with 20 nonunion cases (13 males, 7 females) were included in the study.Of the 20 nonunion cases, 12 had their first treatment in other institutions, but all medical and radiological reports and images; 8 cases originates from our series.Average age was 43 years (range 20¿76).In the first repairing surgery the following hardware were employed: 15 liss or lcpdf (synthes co.); 2 ncb plates (zimmer co.); 1 dcs plate e 2 hybrid external fixators.In the revision surgery a corticocancellous graft harvested from the iliac crest (one or both sides) or with the reamer/irrigator/aspirator (ria) system (depuy synthes).Minimum follow up was three months.The following complications were reported as follows: a case of a (b)(6) year old male (case no.2) who underwent initial surgery with dcs had atrophic nonunion.A case of a (b)(6) year old male (case no.3) who underwent initial surgery with lcp df plate had oligotrophic nonunion.A case of a (b)(6) year old male (case no.4) who underwent initial surgery with lcp df plate had varus malalignment and atropic nonunion.A case of a (b)(6) year old male (case no.5) who underwent initial surgery with lcp df plate had oligotrophic nonunion.A case of a (b)(6) year old female (case no.6) who underwent initial surgery with lcp df plate had varus malalignment and oligotropic nonunion.A case of a (b)(6) year old male ( case no.7) who underwent initial surgery with lcp df plate had varus malalignment and oligotropic nonunion.A case of a (b)(6)year old male (case no.8) who underwent initial surgery with lcp df plate had oligotrophic nonunion.A case of a (b)(6) year old female (case no.10) who underwent initial surgery with lcp df plate had varus malalignment and atropic nonunion.A case of a (b)(6) year old male (case no.12) who underwent initial surgery with lcp df plate had varus malalignment and atropic nonunion.A case of a (b)(6) year old female (case no.13)who underwent initial surgery with lcp df plate had atrophic nonunion.A case of a (b)(6) year old female (case no.14) who underwent initial surgery with lcp df plate had oligotrophic nonunion.A case of a (b)(6) year old male (case no.15) who underwent initial surgery with lcp df plate had varus malalignment and oligotropic nonunion.A case of a (b)(6) year old male (case no.16) who underwent initial surgery with lcp df plate had atrophic nonunion.A case of a (b)(6) year old female (case no.17) who underwent initial surgery with lcp df plate had varus malalignment and oligotropic nonunion.A case of a (b)(6) year old male (case no.19) who underwent initial surgery with lcp df plate had varus malalignment and atropic nonunion.A case of a (b)(6) year old female (case no.20 ) who underwent initial surgery with lcp df plate had atrophic nonunion.In all cases of nonunion except one we found an unbalanced fixation according to the above criteria.An axial defect, in most cases in varus, due to lateralization of the diaphyseal fragment, was observed in more than half cases.All cases except one present a medial cortical bone defect of greater or lesser extent.This case was a failure of a liss.The axis was restored and no medial cortical defect was detected.The patient was severely obese and osteoporotic.We revised it with a megaprosthesis.All nonunions healed.Four of 20 cases needed secondary revision surgery to achieve union.This report is for an unknown synthes liss construct.It captures a case of an unbalanced fixation.All cases except one present a medial cortical bone defect of greater or lesser extent.This case was a failure of a liss.The axis was restored and no medial cortical defect was detected.The patient was severely obese and osteoporotic.We revised it with a megaprosthesis.This is report 7 of 9 for (b)(4).Additional devices are reported under related complaint (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: 10795872
• MDR Text Key: 217309240
• Report Number: 8030965-2020-08686
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 10/13/2020

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: 10/13/2020
• 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