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

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

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown locking compression plate and screw construct/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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, 'cui, x.Et al.(2019), fibular strut allograft influences reduction and outcomes after locking plate fixation of comminuted proximal humeral fractures in elderly patients: a retrospective study, bmc musculoskeletal disorders', vol.20(511), pages 1-8 (china).This study aimed to compare the radiological and clinical outcomes between locking compression plate (lcp) fixation and lcp fixation with fibular allograft implantation for the treatment of comminuted proximal humeral fractures (phfs).Between january 2014 and may 2017, a total of 60 patients (26 men and 34 women) underwent an open reduction and internal fixation using a proximal humeral lcp (synthes, oberdorf, switzerland) ,and no.2 nonabsorbable sutures (ethicon, somerville, usa).The lcp group comprised 35 patients with the mean follow-up period was 32.23 (range, 25¿40) months.The fa group consisted of 25 patients with the mean follow-up period was 31.56 (range, 24¿40) months.The following complications were reported as follows: 5 patients had varus malunion; 2 patients had avascular necrosis; 2 patients developed avascular necrosis of the humeral head.6 patients had screw penetration; this report is for an unknown synthes locking compression plate (lcp) and screws construct.It captures the reported 6 screw penetration.A copy of the literature article is being submitted with this medwatch.This is report 7 of 7 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PLATE/SCREWS
• 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: 10770856
• MDR Text Key: 214132396
• Report Number: 8030965-2020-08475
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• 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: 10/06/2020
• 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