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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Hematoma (1884); Nerve Damage (1979); Hypoesthesia (2352); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for unknown plate.Part#, lot# and udi # is not available.Device is not expected to be returned for manufacturer review/investigation.This report is for unknown plate.Pma/510(k) number is not available.(b)(4).Product was not returned.Device history records review could not be completed without lot number.Based on the information available, it has been determined that no corrective and 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

This report is being filed after the review of the following journal article: t.Westphal, s.Woischnik, d.Adolf, h.Feistner, s.Piatek (2017), axillary nerve lesions after open reduction and internal fixation of proximal humeral fractures through an extended lateral deltoid-split approach: electrophysiological findings, journal of shoulder and elbow surgery, pages 464-471 (germany).The aim of this study was to determine the frequency of axillary nerve lesions after open reduction and internal fixation of proximal humeral fractures by using electrophysiological assessments and to provide a review of the relevant literature.From january 2005 to december 2008, 76 patients underwent open reduction and internal fixation of a proximal humeral fracture through an extended deltoid-splitting approach.Fracture fixation was achieved using a philos plate (synthes inc., umkirch, germany).Of 76 patients who were eligible for participation, 9 were excluded.The minimum follow-up interval was at least 12 months.Of 67 patients who were invited for follow-up, 40 patients could be assessed for the final study because 9 patients had died, 12 refused to participate, and 6 could not be located (fig.1).The follow-up included a survey, a clinical examination of the shoulder, and an electrophysiological assessment.During the survey, patients were asked to complete the disabilities of the arm, shoulder, and hand (dash) questionnaire and all required questions for completing the constant-murley score.The electrophysiological assessment of the axillary nerve included electromyography (emg) of the involved deltoid muscle and electroneurography (eng) of the axillary nerve, and the results were compared with those of the healthy shoulder.The following complications were reported as follows: 9 patients were included but were not followed because they died as seen in figure 1.11 patients underwent additional surgery because of complications or implant removal before the electrophysiological assessments were performed.1 patient had an early revision due to hematoma drainage.1 patient had an early revision due to superficial infection.1 patient had an early revision due to deep infection.1 patient presented with atrophy of the clavicular part of the deltoid muscle.3 patients described paresthesias in the autonomous sensory area of the axillary nerve.1 patient showed a combination of atrophy and paresthesia.3 patients had signs of axonotmesis with complete reinnervation.3 patients had signs of axonotmesis with complete reinnervation.1 patient showed signs of neurotmesis.1 patient displayed atrophy of the deltoid and dysesthesia at an autonomous area.2 patients had dysesthesia.1 patient showed atrophy.1 patient had dysesthesia without electrophysiological signs of the 11 patients who underwent additional surgery, 4 showed an axillary nerve lesion, whereas only 3 of 29 patients without additional operations showed lesions.The axillary nerve lesion was permanent in 3 of these 4 patients.This report is for an unknown proximal humeral interlocking system (philos) plate.This is report 1 of 2 for (b)(4).

• 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 8344955
• MDR Text Key: 136326069
• Report Number: 8030965-2019-61080
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• 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: 01/25/2019
• 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