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

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

Patient Problems Pain (1994); Scarring (2061); Discomfort (2330); Hypoesthesia (2352); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown matrixrib plates/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.(b)(4).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: hwee j., et al (2020) results and long-term functional outcomes of rib fracture fixation: a case series in singapore and a review of indications for surgical fixation, annals, academy of medicine, singapore vol.49 no.2, pages 93-97 (singapore).This retrospective study aims to describe the results and long-term functional outcomes of our experience with rib fracture fixation.Between 2012¿2016, a total of 21 patients (16 males and 5 females) with a mean age of 66.5 (range, 19-77) years old who underwent rib fracture fixation were included in the study.Fixation was done using a precontoured titanium rib locking 1.5 mm plates (matrixrib¿, depuy synthes).The mean follow-up period was 2.7 (range, 2.5¿5.8) years.The following complications were reported as follows: -one patient had a fixation screw that became partially detached from the plate (the patient was asymptomatic and was treated conservatively).-the sole patient gave a score of 3 for patient satisfaction with the results of the operation due to the loosening of a screw, which he felt limited his initial rehabilitation.-two patients complained of chest numbness, and 1 had areas of hypertrophic scarring.-7 patients had pain on exertion only.-2 patients had experienced discomfort on deep breathing.-2 of patients experienced significant pain, which lasted for >1 year.Both patients suffered from diabetes mellitus, -14 patients were unable to do strenuous activities.-1 patient had deceased.This report is for an unknown synthes precontoured titanium rib locking plates matrixrib.It captures the reported cases of 1 patient who had hypertrophic scarring, 7 patients had pain on exertion only, 2 patients had discomfort on deep breathing, 2 patients experienced significant pain, and 14 patients were unable to do strenuous activities.This is report 2 of 3 for complaint (b)(4).

• Brand Name: UNK - PLATES: MATRIXRIB
• 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: 10026905
• MDR Text Key: 194489054
• Report Number: 8030965-2020-03308
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2020
• 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