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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNKNOWN - ROD ROD, FIXATION, INTRAMEDULLARY

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SYNTHES GMBH UNKNOWN - ROD ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hematoma (1884)
Event Date 01/01/2021
Event Type  Injury  
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(4) 2021, the patient required revision surgery for a hematoma. One (1) unknown locking screw, one (1) unknown trauma screw, and one (1) unknown rod were removed from the patient. The patient was revised with larger unknown matrix screws and unknown tpal cage. There is no further information available. This report is for one (1) unknown rod. This is report 3 of 3 for (b)(4).
 
Manufacturer Narrative
Additional narrative: event occurred on an unknown date in 2021. This report is for an unknown rod/unknown lot. Part and lot numbers 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. 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
Additional narrative: event occurred on an unknown date in 2021. This report is for an unknown rod/unknown lot. Part and lot numbers 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. 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) 2021, the patient required revision surgery for a hematoma. One (1) unknown locking screw, one (1) unknown trauma screw, and one (1) unknown rod were removed from the patient. The patient was revised with larger unknown matrix screws and unknown tpal cage. There is no further information available. This report is for one (1) unknown rod. This is report 3 of 3 for (b)(4).
 
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Brand NameUNKNOWN - ROD
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13482139
MDR Text Key285260158
Report Number8030965-2022-00754
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/08/2022 Patient Sequence Number: 1
Treatment
UNK - SCREWS: LOCKING.; UNK - SCREWS: TRAUMA.
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