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

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

Patient Problems Unspecified Infection (1930); Pain (1994); Thrombosis (2100); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown unk - constructs: plate/screws/unknown lot number.Without the specific part number, the udi number and 510k 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 as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.Investigation summary 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.(b)(4).

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that this report is being filed after the review of the following journal article: marden s., landmn, f., and schwabe, p.(2015), outcome of angular stable locking plate fixation of tibial plateau fractures midterm results in 101 patients, indian journal of orthopedics, vol.49(6), pages, 620-629 (germany).The present study is aimed to investigate the clinical, radiological, functional and quality of life results following tibial plateau fractures using angular stable plate fixation.Between january 1999 and june 2011, a total of 101 patients (46 males and 55 females) with a mean age of 51 years (range 22-77 years) were treated with a 3.5 mm locking compression plate [lcp] proximal tibia, 3.5/4.5 mm l-/t-shaped lcp, synthes gmbh, umkirch, germany).The mean follow up was 57.3 ± 30.4 months (range 19-154 months).The following complications were reported as follows: 15 patients died.Final follow up radiograph showing a loss of reduction of more than 2 mm in the condylar height compared to the initial postoperative radiograph.In 69.3% of all patients, mostly b3-fractures, defect filling was necessary.Type of the bone substitute used for defect reconstruction did not influence final outcome.Quantitative analysis of secondary loss of reduction more than 2 mm when compared to postoperative radiographs was found in 22, while loss of reduction did not exceed 2 mm in 12 (11.9%) with an unchanged reduction in 67 patients.As expected, type b-fractures were found to show significantly less loss of reduction compared to multifragmentary type c-fractures (0.43 ± 0.79 vs.1.10 ± 1.28; p < 0.001).62.4% of all patients showed either no radiographic sign of oa or only grade i.Further analysis of the influence of different fracture types on incidence of oa displayed a significantly (p < 0.001) increased oa rate (2.21 ± 1.36 vs.0.79 ± 0.97) following type-c-fractures.Investigating the relationship between postoperative malalignment and oa revealed that valgus malalignment resulted in a significantly higher osteoarthritis score (2.82 ± 1.24 vs.1.02 ± 1.12; p < 0.001) as opposed to varus malalignment that did not differ significantly (1.9 ± 1.45 vs.1.26 ± 1.3; p = 0,211).Regarding the defined categories the total kss was found to be fair in 8.9% and poor in 16.8%.In a subgroup analysis significant higher rest pain scores following type-c-fractures were found when compared to b-fractures (1.95 ± 1.59 vs.1.27 ± 1.54; p = 0.0039).8 patients had a deep venous thrombosis was diagnosed.6 patients had deep infections.They were successfully treated either with local wound care/antibiotics or surgical debridement/antibiotics.1 patient had a prolonged course (125 days) due to a deep joint infection after open fracture, which could be managed by programmed and serial revision surgeries and long term intravenous-antibiotics.2 patients had loose screws which were revised and screws wither replaced or removed.This report is for a 3.5 mm locking compression plate [lcp] proximal tibia, 3.5/4.5 mm l-/t-shaped lcp, synthes gmbh, umkirch, germany).This impacted product captures the reported defect filling, secondary loss of reduction, radiographic sign of osteoarthritis, fir and poor kss results, pain, deep venous thrombosis, deep infections this report is for one (1) unk - constructs: plate/screws-tibia.This report is 1 of 2 for (b)(4).A copy of the literature article is being submitted with this medwatch.

• Brand Name: UNK - CONSTRUCTS: PLATE/SCREWS-TIBIA
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6103142063
• MDR Report Key: 9158771
• MDR Text Key: 165758704
• Report Number: 8030965-2019-69074
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 09/12/2019
• Initial Date FDA Received: 10/04/2019
• 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