MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: LCP; PLATE, FIXATION, BONE

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown lcp 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: de loos, e.R.Et al.(2020), does the use of locking plates or mesh and wires influence the risk of symptomatic non-union of the sternal osteotomy after modified ravitch?, journal of thoracic disease, vol.12(7), pages 3631-3639 (netherlands).The aim of this retrospective cohort study is to evaluate the use and outcome of a new fixation method of the sternal osteotomy in the modified ravitch procedure using lcps.From march 2006 to march 2012, the sternum was fixated with cerclage wires and nonabsorbable retrosternal mesh support as the standard of care.From march 2012 to september 2016, lcps were used for fixation.In the lcp group, the osteotomy was rigidly fixated by two 3.5 millimeters 6 to 8-hole metaphyseal or diaphyseal titanium lcps (depuy synthes, johnson&johnson, amersfoort, the netherlands).A total of 44 patients (28 men, 16 women) with a median age of 48 years(range, 20¿72) were included.The mean follow-up was 30 months in the lcp group (range, 2¿73).The following complications were reported as follows: 6 patients requested to remove the plates.All these patients were bothered by implant prominence and therefore asked for hardware removal.1 patient presented with pectoral muscle dehiscence.1 patient presented with seroma.2 patients presented with wound infections.This report is for an unknown synthes lcp.It captures the reported events of pectoral muscle dehiscence, seroma and wound infections.(b)(4).This is report 2 of 2 for complaint (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H6: the investigation could not be completed; no conclusion could be drawn, as no product was received.Product was not returned.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.

• Brand Name: UNK - CONSTRUCTS: LCP
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12506375
• MDR Text Key: 272472305
• Report Number: 8030965-2021-07893
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/27/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention