MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: VEPTR; PROSTHESIS, RIB REPLACEMENT

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Wound Dehiscence (1154); Failure of Implant (1924); Unspecified Infection (1930); Pocket Erosion (2013)

Event Date 07/01/2021

Event Type  Injury  

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.Brand name, common device name/procode, manufacturer name, city and state, model#, catalog #, serial #, lot#, expiration date, other #, udi# , date received by manufacturer: ¿ 510k: this report is for an unknown device/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: johnson, m.A.Et al (2021), rib-based distraction device implantation before age 3 associated with higher unplanned rate of return to the operating room, journal of pediatric orthopedics, vol.41 (6), pages e369¿e373 (usa).The aim of this retrospective study is to provide insight into the risks for patients with eos being treated with initial implant surgery before the age of 3.Between 2007 and 2016, a total 137 patients with an average age of 4.1 ±3.3 years that were surgically treated with veptr device were included in the study.Among these, 68 patients underwent device implantation between the ages of 0 to 2 years old (case-cohort) and 69 patients were implanted between 3 and 10 years old (comparison cohort).There was no difference between the 0- to 2-year and 3- to 10-year old groups in regard to the proportion of female patients (41% vs.51%, p = 0.262), bmi (17.1 ± 3.1 vs.17.3 ± 3.0, p = 0.552), age-adjusted bmi z-score (0.1 ± 1.7 vs.0.5 ±1.4, p= 0.173), and follow-up time (4.8 ± 2.1 vs.4.7 ±2.0, p = 0.872).The following complications were reported as follows: 76 (56%) patients requiring at least 1 unplanned reoperation.There were a higher proportion of patients aged 0 to 2 undergoing at least 1 unplanned reoperation compared with patients aged 3 to 10 years (65% vs.46%, p = 0.031) (fig.2).Of all patients requiring an unplanned reoperation, 38% were within 1 year of their initial implantation surgery (fig.3).Subjects who required a reoperation underwent an average of 2.6 ±1.9 unplanned procedures in the 0- to 2-year group, similar to 2.3 ± 1.7 in the 3- to 10-year group (p= 0.508) (table 1).All complications leading to reoperation were classified as device-related 2a or 2b according to the system defined by smith et al.14 of patients aged 0 to 2 undergoing reoperations, 34 (77%) had at least 1 device-related 2b complication compared with 17 (53%) patients aged 3 to 10 years old (p= 0.027).All complications leading to reoperation were categorized as either infection/wound dehiscence/exposed implant, device migration, or prominent implant with 48% of all patients having at least 1 wound-related reoperation.Of patients experiencing at least 1 wound-related complication, 48 (73%) retained their implant and did not require hardware removal.There was no difference in implant retention between patients aged 0 to 2 (79%) and those aged 3 to 10 (64%) years old (p =0.186).This report is for an unk - construct: veptr.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: VEPTR
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA ; 3035526892
• MDR Report Key: 15361160
• MDR Text Key: 299293225
• Report Number: 8030965-2022-06397
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• 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: 08/10/2022
• 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): Other