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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; PLATE, FIXATION, BONE
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OBERDORF SYNTHES PRODUKTIONS GMBH; PLATE, FIXATION, BONE Back to Search Results
Device Problem Break (1069)
Patient Problems Pain (1994); Swelling (2091); No Code Available (3191)
Event Date 01/01/2019
Event Type  Injury  
Manufacturer Narrative
Date of event is an unknown date in 2019.This report is for an unknown plate/unknown lot.Part and lot number 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.(b)(4).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 (b)(6) reports an event as follows: it was reported that in an x-ray taken on (b)(6) 2019, an unknown plate was noted to be broken.The patient originally had implantation of the osteosynthesis plate on (b)(6) 2019.However, a breakage of the built-in plate in distal part (below the 8th hole of proximal, where the first two (2) holes on an altitude are numbered) with transverse fracture in the ventral and dorsal screw hole was first noticed on an x-ray.The patient could not remember the exact moment of the breakage.It is unknown if revision surgery has been scheduled.Patient status is unknown.Concomitant devices: screws (part: unknown, lot: unknown, quantity: unknown).This report is for an unknown plate.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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
It was reported that on an unknown date, an unknown plate was noted broken as showed in an x-ray during a routine post-surgery consultation on (b)(6) 2019.Initially, the patient was implanted with an unknown osteosynthesis plate on (b)(6) 2019 due to tibial fracture with partial articular split and fragmentary metaphysial fracture (ao-classification:43.However, a breakage of the built-in plate in distal part (below the 8th hole of proximal, where the first two (2) holes on an altitude are numbered) with transverse fracture in the ventral and dorsal screw hole was first noticed on an x-ray.The patient could not remember the exact moment of the breakage.It was only found out during examination that there was a tibio-talar joint swelling and a slight pressure dependent pain on the medial distal tibia.There is no plan of a revision surgery considering the low pain of the patient, age and comorbidities.Fragments were retained in the patient's body.It was decided to immobilized the ankle joint with a long walker for six weeks.Patient is still recovering.Concomitant device reported: unknown screws (part# unknown, lot# unknown, quantity unknown).
 
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.This report is for an unknown tibia plates/unknown lot.Part and lot numbers are unknown; udi 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
It was further reported that the patient is in a good and stable condition.In further examinations, it was found out that there was a slow healing with a slight bending of the fracture.Therefore, the immobilization was continued.
 
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
It was reported that on an unknown date, an unknown plate was noted broken as showed in an x-ray during a routine post-surgery consultation on (b)(6) 2019.Initially, the patient was implanted with an unknown osteosynthesis plate on (b)(6) 2019 due to tibial fracture with partial articular split and fragmentary metaphysial fracture (ao-classification:43 b1.3).However, a breakage of the built-in plate in distal part (below the 8th hole of proximal, where the first two (2) holes on an altitude are numbered) with transverse fracture in the ventral and dorsal screw hole was first noticed on an x-ray.The patient could not remember the exact moment of the breakage.It was only found out during examination that there was a tibio-talar joint swelling and a slight pressure dependent pain on the medial distal tibia.There is no plan of a revision surgery considering the low pain of the patient, age and comorbidities.Fragments were retained in the patient's body.It was decided to immobilized the ankle joint with a long walker for six weeks.Patient is still recovering.Concomitant device reported: unknown screws (part# unknown, lot# unknown, quantity unknown).
 
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.Additional narrative: 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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Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key8574668
MDR Text Key143870503
Report Number8030965-2019-63402
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received02/13/2020
Patient Sequence Number1
Treatment
UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA
Patient Outcome(s) Required Intervention;
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