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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - ARCOFIX/TELEFIX/VENTROFIX IMPLANTS: TELEFIX; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
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SYNTHES GMBH UNK - ARCOFIX/TELEFIX/VENTROFIX IMPLANTS: TELEFIX; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Discomfort (2330)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown implant/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.Initial reporter is synthes employee 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 the osteosynthesis material, implanted on an unknown date in 2013, has been causing the patient pain and discomfort.It was partially removed on an unknown date in 2014.No further information was provided.This report is for one (1) unknown arcofix/telefix/ventrofix.This is report 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.
 
Event Description
This is report 1 of 6 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.D1, d2, d3, d4, g4-510k: this report is for an unknown telefix screw posterior 7x35mm/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.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 for one (1) telefix screw posterior 7x35mm.
 
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Brand Name
UNK - ARCOFIX/TELEFIX/VENTROFIX IMPLANTS: TELEFIX
Type of Device
ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key12041696
MDR Text Key257480246
Report Number8030965-2021-05170
Device Sequence Number1
Product Code MNH
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 06/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2021
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 Received08/13/2021
Patient Sequence Number1
Treatment
UNK - ARCOFIX/TELEFIX/VENTROFIX IMPLANTS: TELEFIX; UNK - ARCOFIX/TELEFIX/VENTROFIX IMPLANTS: TELEFIX; UNK - ARCOFIX/TELEFIX/VENTROFIX IMPLANTS: TELEFIX; UNK - ARCOFIX/TELEFIX/VENTROFIX IMPLANTS: TELEFIX; UNK - ARCOFIX/TELEFIX/VENTROFIX IMPLANTS: TELEFIX; UNK - ARCOFIX/TELEFIX/VENTROFIX IMPLANTS: TELEFIX; UNK - ARCOFIX/TELEFIX/VENTROFIX IMPLANTS: TELEFIX; UNK - ARCOFIX/TELEFIX/VENTROFIX IMPLANTS: TELEFIX; UNK - ARCOFIX/TELEFIX/VENTROFIX IMPLANTS: TELEFIX; UNK - ARCOFIX/TELEFIX/VENTROFIX IMPLANTS: TELEFIX; UNK - ARCOFIX/TELEFIX/VENTROFIX IMPLANTS: TELEFIX; UNK - ARCOFIX/TELEFIX/VENTROFIX IMPLANTS: TELEFIX; UNK - ARCOFIX/TELEFIX/VENTROFIX IMPLANTS: TELEFIX
Patient Outcome(s) Required Intervention;
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