• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SYNTHES GMBH UNK - PLATES: TRAUMA PLATE, FIXATION, BONE Back to Search Results
Catalog Number UNK - PLATES: TRAUMA
Device Problem Break (1069)
Patient Problems Pain (1994); Discomfort (2330); Non-union Bone Fracture (2369); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/01/2021
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Additional narrative: this report is for an unk - nails/unknown lot. Part and lot numbers are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. (b)(4). 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. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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
Patient initiated complaint: the patient stated, " it was broken in my legs in (b)(6) they put nail in my legs and it ended up breaking. They have to remove that part from my leg and put on (b)(6) 2021. I have rehab and doctors are care ever since. I appreciate a phone call. Please make synthes aware of the updated information. The patient did not know the manufacturer of the plate that broke. Since the number he called originally was provided by the surgeon who revised the broken plate, it would be a fair assumption that the plate may be a synthes plate. It should be noted that there may have been some misunderstandings in communication due to difficulty in hearing. ".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNK - PLATES: TRAUMA
Type of DevicePLATE, FIXATION, BONE
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 Key13713470
MDR Text Key288775844
Report Number8030965-2022-01477
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/09/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received03/09/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK - PLATES: TRAUMA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received04/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/09/2022 Patient Sequence Number: 1
Treatment
UNK - SCREWS: TRAUMA.
-
-