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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - BIOMATERIAL - PREFORMED; ORTHOSIS,PEDICLE,SPINAL FIXATION
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SYNTHES GMBH UNK - BIOMATERIAL - PREFORMED; ORTHOSIS,PEDICLE,SPINAL FIXATION Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Date 01/01/2020
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown preformed biomaterial/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 an unknown date in (b)(6) 2020, a bone graft was implanted and then rejected.It became swollen and turned purple.The patient underwent corrective surgery on (b)(6) 2020, and the implants were removed.No further information was provided.This is report 5 of 10 for (b)(4).This complaint has been updated with the 10 out of 21 devices.Please see the linked complaints (b)(4) and (b)(4) for the additional eleven devices.Product code: unk-plate: tibia, lot #: unk, quantity: 1 (b)(4), product code: unk-plate: tubular, lot #: unk, quantity: 1 (b)(4), product code: unk-screws: locking, lot #: unk, quantity: 12 (b)(4), product code: unk-screws: cortex, lot #: unk, quantity: 6 (b)(4).
 
Event Description
It was reported that a patient underwent an osteosynthesis of the tibia and fibula in (b)(6) 2019, and then in (b)(6) 2020 a bone graft was placed and it was rejected, it became swollen and turned purple.On (b)(6) 2020 the implants were removed.The implants used according to the radiographs are medial distal tibia plate and 1/3 3.5 tube plate with 3.5 locked and cortical screws.
 
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.
 
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 - BIOMATERIAL - PREFORMED
Type of Device
ORTHOSIS,PEDICLE,SPINAL FIXATION
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key10689982
MDR Text Key215895099
Report Number8030965-2020-07990
Device Sequence Number1
Product Code MNI
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 09/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2020
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 Received12/11/2020
Patient Sequence Number1
Treatment
UNK - PLATES: TIBIA; UNK - PLATES: TUBULAR; UNK - SCREWS: CORTEX; UNK - SCREWS: LOCKING
Patient Outcome(s) Required Intervention;
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