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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - CONSTRUCTS: VEPTR; PROSTHESIS, RIB REPLACEMENT
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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - CONSTRUCTS: VEPTR; PROSTHESIS, RIB REPLACEMENT Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown unk - constructs: veptr/unknown lot number.Without the specific part number, the udi number and 510k 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 as no product was received.The investigation summary could not be completed; no conclusion could be drawn at the time of filing this report.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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
Device report from synthes europe reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: catteruccia m.Et, al (2017), scoliosis is an inescapable comorbidity in sma type ii.A single center experience, acta myologica vol.36(2), page 87 (italy).This study presents a data of progression of scoliosis and treatment in a cohort of 20 sma type ii patients followed in the last 15 years between 2002 and 2017.A total of 20 patients (age range, 2-20 years) were included in the study.Of these patients, 6 patients with a mean age of 8.1 (range, 6.2-10 years) were treated with unknown synthes veptr.All patients underwent systematical x-ray, functional and pulmonary assessments.Follow-ups were unknown.The article did not specify which of the devices were being used to capture the following complications: 3 patients had urinary infection, difficulty in extubation and weaning from mechanical ventilation and infective complication of the surgical wound.This report is for an unknown synthes veptr.This report is 1 of 1 for (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.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.
 
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Brand Name
UNK - CONSTRUCTS: VEPTR
Type of Device
PROSTHESIS, RIB REPLACEMENT
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key8824514
MDR Text Key152160030
Report Number8030965-2019-66554
Device Sequence Number1
Product Code MDI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Type of Report Initial,Followup
Report Date 07/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2019
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 Received07/31/2019
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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