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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5 MM LOCKING SCREW 26 MM LENGTH SCREW, FIXATION, BONE

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ZIMMER BIOMET, INC. 3.5 MM LOCKING SCREW 26 MM LENGTH SCREW, FIXATION, BONE Back to Search Results
Model Number N/A
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Patient Problems Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/28/2018
Event Type  Injury  
Event Description
Zimmer biomet received an anonymized study report summarizing the data of the titanium universal locking system when used for long bones collected on a clinical study. It was reported that a screw was removed before union due to unknown reason. Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
(b)(4). Concomitant product: universal locking system titanium plate. Report source: foreign country: (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the location of the device is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
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Brand Name3.5 MM LOCKING SCREW 26 MM LENGTH
Type of DeviceSCREW, FIXATION, BONE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
1800 w. center st.
warsaw IN 46580
Manufacturer (Section G)
ZIMMER BIOMET, INC.
1800 w. center st.
warsaw IN 46580
Manufacturer Contact
jennifer rapsavage
56 e. bell dr.
warsaw, IN 46582
5745260384
MDR Report Key14675311
MDR Text Key293912012
Report Number0001822565-2022-01777
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K081759
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 10/12/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received06/13/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number47236902635
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received09/16/2022
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? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 06/13/2022 Patient Sequence Number: 1
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