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

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

Patient Problem Nerve Damage (1979)

Event Type  Injury  

Manufacturer Narrative

This report is for an unk - constructs: philos plate/screws/unknown lot.Part and lot numbers are unknown; udi 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.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: yang, y.L.Et al.(2020), treatment of chronic anterior shoulder dislocation by coracoid osteotomy with or without bristow¿latarjet procedure, orthopaedic surgery, vol.12, number 5, pages 1478-1488 (china).The purpose of this study is as follows: (i) to summarize and observe the clinical features of chronic anterior shoulder dislocation; (ii) to report the effectiveness and clinical outcome of patients with chronic anterior shoulder dislocation treated with coracoid osteotomy with or without bristow¿latarjet procedure; (iii) to explore the advantages of the coracoid osteotomy in the treatment of chronic anterior shoulder dislocation.Between january 2013 and january 2019, a total of 20 shoulders of 18 patients who were diagnosed with chronic anterior dislocation and underwent open reduction.Open coracoid osteotomy with bristow¿latarjet procedures were performed on 16 shoulders and open coracoid osteotomy without bristow¿latarjet procedures were performed on four shoulders.There were three males and 15 females with an average age of 60.94 +/ 2.69 years.The proximal humeral fractures were treated with philos plates in 2 shoulders.The following complications were reported as follows: an axillary nerve injury was suspected because of numbness of lateral skin of the shoulder in one patient postoperatively, and they recovered 1 month after surgery this report is for an unknown philos plate.This report is for one (1) unk - constructs: philos plate/screws.This is report 1 of 1 for complaint (b)(4).

• Brand Name: UNK - CONSTRUCTS: PHILOS PLATE/SCREWS
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11974739
• MDR Text Key: 267352147
• Report Number: 8030965-2021-04760
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• 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: 05/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1