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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNKNOWN- VEPTR IMPLANTS: VEPTR II; PROSTHESIS, RIB REPLACEMENT
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OBERDORF SYNTHES PRODUKTIONS GMBH UNKNOWN- VEPTR IMPLANTS: VEPTR II; PROSTHESIS, RIB REPLACEMENT Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Foreign Body Reaction (1868)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown prosthesis/unknown lot.Part and lot numbers are unknown; udi number is unknown.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, the surgeon took the vertical expandable prosthetic titanium rib (veptr) ii rib to spine construct out of the patient due to a standard procedure for the end of expansion.The surgeon took a photograph of the construct, leaving an unknown rib hook which showed metallosis.The unknown rib hook was left inside the patient to connect a new rod for the new construct.The procedure was completed successfully with no surgical delay.There was no other medical intervention required.This report is for one (1) unknown - veptr implants: veptr ii this is report 1 of 2 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.Investigation summary: picture reviewed, there are dark spots visible in the open wound, but just based on the picture no statement about the origin can be made.Product was not returned and no article- and lot number was provided.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
Update 1/3/2019: per reporter, the patient's age is unknown, due to patient confidentiality, patient maybe between the ages of 10-12 years old.
 
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.Updated information provided by reporter.Reporters state is england.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
UNKNOWN- VEPTR IMPLANTS: VEPTR II
Type of Device
PROSTHESIS, RIB REPLACEMENT
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key8203012
MDR Text Key131617540
Report Number8030965-2018-59299
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 company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 12/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2018
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 Received01/03/2019
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age12 YR
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