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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL STERILE LATARJET SCREW, 30MM SOFT-TISSUE, ANCHOR, NON-BIOABSORBABLE

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MEDOS INTERNATIONAL SàRL STERILE LATARJET SCREW, 30MM SOFT-TISSUE, ANCHOR, NON-BIOABSORBABLE Back to Search Results
Catalog Number 288223
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032)
Event Date 07/28/2017
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4).
 
Event Description
It was reported by the affiliate that after an unknown procedure that was performed on (b)(6) 2017, the patient complained about pain, stiffness, and reduced motion range. The patient had a revision surgery, on (b)(6) 2019, which stabilized the joint and increased their range of motion. The dr. Removed the latarjet screws, adhesions, arthroscopically.
 
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Brand NameSTERILE LATARJET SCREW, 30MM
Type of DeviceSOFT-TISSUE, ANCHOR, NON-BIOABSORBABLE
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer (Section G)
MEDOS INTERNATIONAL SARL
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key8367104
MDR Text Key137043378
Report Number1221934-2019-56480
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K110763
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/01/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2022
Device Catalogue Number288223
Device Lot NumberL245144
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/19/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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