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

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.

• Brand Name: STERILE LATARJET SCREW, 30MM
• Type of Device: SOFT-TISSUE, ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; 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 Key: 8367104
• MDR Text Key: 137043378
• Report Number: 1221934-2019-56480
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K110763
• Number of Events Reported: 1
• 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 Received: 02/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 288223
• Device Lot Number: L245144
• 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 Received: 03/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2017
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown