MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; PLATE FIXATION, BONE

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

Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091); Reaction (2414); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown plate/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.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, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.(b)(4).

Event Description

Device report from synthes reports an event in ireland as follows: this report is being filed after the review of the following journal article: moriarity, a., et al (2018), a comparison of complication rates between locking and non-locking plates in distal fibular fractures, orthopaedics and traumatology: surgery and research, vol.104(4), pages 503-506 (ireland).The aim of this study is to assess the complication rates of locking plates versus non-locking plates for the treatment of distal fibular fractures.Between january 2012 and december 2014, a total of 129 patients (64 male and 65 female) with mean age of 39.1 and age range of 18-85 years underwent a surgical fixation of distal fibular fractures was done using unknown synthes limited compression plate (lcp) metaphyseal locking plate.Routine follow-up included wound review at 2 weeks and radiographic evaluation at 2, 6 and 12 weeks postoperatively.The patients remained non-weight bearing in either a below knee cast or aircast for 4 weeks and progressed to full weight-bearing status by week 6 postoperatively.The following complications were reported as follows: 5 cases of minor wound infection.15 cases of minor secondary complications such as prominence or irritability of metal, ankle swelling and ankle pain (not requiring analgesia).2 cases of major secondary complications such as failure of metal work, nonunion, malunion, removal of metal or revision surgery.9 cases of plate removal due to pain or metal irritability.These impacted products capture the following adverse events: minor wound infection, minor secondary complications.This report is for an unknown synthes limited compression plate (lcp) metaphyseal locking plate.This report is 1 of 6 for (b)(4).A copy of the literature article is being submitted with this medwatch.

• 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: 9014185
• MDR Text Key: 161797054
• Report Number: 8030965-2019-68235
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/16/2019

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: 08/16/2019
• Initial Date FDA Received: 09/12/2019
• 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