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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: TIBIA PLATE, FIXATION, BONE

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SYNTHES GMBH UNK - PLATES: TIBIA PLATE, FIXATION, BONE Back to Search Results
Catalog Number UNK - PLATES: TIBIA
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/20/2021
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4). Pma/510k: this report is for an unk plates: tibia /part and lot numbers are unknown; udi number is unknown. Without the specific part number the device history records review could not be completed; and the udi number is unknown. Complainant device is not expected to be returned for manufacturer review/investigation. Investigation summary: product was not returned. Based on the information available, it has been determined that no corrective and 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 underwent open reduction internal fixation surgery for fracture of proximal end of tibia. For tibial plateau fracture, the surgeon tried to fix with a medial proximal tibia plate from posterior side. Because the operative field was deep and narrow, the sales rep instructed the surgeon to perform the procedures according to the usf surgical technique and catalog. Surgery was performed according to that surgical technique and completed within 30 minutes delay. Based on the event "another surgeon noticed this, reattached the threaded guide properly again, and fixed the plate. No further information is available. This complaint involves four (4) devices. This report is for one (1) unk: plates: tibia. This report is 4 of 4 for (b)(4).
 
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Brand NameUNK - PLATES: TIBIA
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 
MDR Report Key12037685
MDR Text Key268140283
Report Number8030965-2021-05157
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 05/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK - PLATES: TIBIA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Unkown

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