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

Device Problem No Apparent Adverse Event (3189)

Patient Problem Osteolysis (2377)

Event Date 05/01/2010

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown plate/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: robinsons, c.M., et al (2010), proximal humeral fractures with a severe varus deformity treated by fixation with a locking plate,the bone and joint journal, volume 92-b, number 5, pages 672-678 (unite kingdom) doi:10.1302/0301-620x.92b5.22849.This study aims to describe the anatomical features of fractures of the proximal humerus with varus deformity and an operative technique for its reduction and internal fixation (orif) and evaluate prospectively the functional and radiological outcomes from this treatment in a consecutive series of patients.Between march 2002 and february 2007,a total of 47 patients (21 male and 26 female) with a mean age at the time of operation was 57 years (22 to 88) who underwent open reduction and internal fixation (orif) were included in the study.Fixation was done using 3.5 mm cannulated screws (synthes, welwyn garden city, united kingdom) or acutrak screws (acumed, andover, united kingdom).Definitive fixation was achieved using a proximal humeral locking plate (philos plate; synthes).All the patients were reviewed prospectively by a research assistant at one and six weeks, three and six months and one and two years after their injury.The following complications were reported as follows: two patients developed symptomatic subacromial impingement and underwent open acromioplasty and removal of the metal.Two patients developed post-traumatic stiffness in a capsular pattern.Both were treated successfully by arthroscopic soft-tissue excision of scar tissue in the rotator interval, circumferential capsular release of the glenohumeral joint, excision of subacromial adhesions and acromioplasty.A case of a female patient with failure of fixation with recurrent varus deformity within two weeks of the operation.This patient underwent revision.This patient had subsequently developed stiff shoulders but were free from pain.A case of a female patient with failure of fixation,with recurrent varus deformity within two weeks of the operation, had malposition of the plate and low posteroinferior calcar screws had not been inserted into the lower quadrant of the head.This patient underwent revision surgery.This patient subsequently developed stiff shoulders but were free from pain.A case of a male patient developed progressive osteolysis of the greater tuberosity and had painless loss of active abduction, but with a full range of passive movement.Infraspinatus with atrophy was confirmed by arthroscopy.He underwent removal of the metal and subacromial decompression.His symptoms improved, but he had persistent pain-free restriction of active movement and weakness of the rotator cuff at the final follow-up.A case of a male patient with a mean age of 59 year old had asymptomatic patchy osteolytic and osteosclerotic changes in the humeral head without structural collapse or joint-space narrowing.A case of a male patient with a mean age of 59 year old had asymptomatic patchy osteolytic and osteosclerotic changes in the humeral head without structural collapse or joint-space narrowing.A case of a male patient with a mean age of 59 year old had asymptomatic patchy osteolytic and osteosclerotic changes in the humeral head without structural collapse or joint-space narrowing.A case of a female patient with a mean age of 59 year old had asymptomatic patchy osteolytic and osteosclerotic changes in the humeral head without structural collapse or joint-space narrowing.A case of a female patient with a mean age of 59 year old had asymptomatic patchy osteolytic and osteosclerotic changes in the humeral head without structural collapse or joint-space narrowing.This report is for an unknown proximal humeral locking plate (philos).This is report 1 of 3 for (b)(4).The complaint involves 30 devices.Due to a limit of impacted products per complaint, this complaint will be captured under 4 separate complaints as listed below: (b)(4)¿ this complaint will include 9 devices ¿ 3 plates , and 6 screws (1st pc).(b)(4)¿ this complaint will include 9 devices ¿ 3 plates , and 6 screws (2nd pc).(b)(4)- this complaint will include 9 devices - 3 plates , and 6 screws (3rd pc).(b)(4)- this complaint will include 3 devices - 1 plate, and 2 screws (4th pc).

• Brand Name: UNK - PLATES
• 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: 8915670
• MDR Text Key: 158804935
• Report Number: 8030965-2019-67558
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• 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: 07/25/2019
• 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