MAUDE Adverse Event Report: SYNTHES GMBH 4.5MM TI VA-LCP CRVD CONDYLAR PLATE/6H/159MM/RT-STER; PLATE, FIXATION, BONE

Catalog Number 04.124.406S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Malunion of Bone (4529)

Event Type  Injury  

Manufacturer Narrative

Additional device product codes: hwc and jdp.Complainant part is not expected to be returned for manufacturer review/investigation.Therapy date: (b)(6) 2022, product code: 04.124.406s, lot number: 29p7909, manufacturing site: mezzovico, release to warehouse date: 20 dec 2019, expiration: 01 dec 2029.A manufacturing record evaluation was performed for the sterile lot number, and no non-conformances were identified.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 an unknown date, shortly after the intervention there was loss of fracture reduction, dehiscence of the surgical wound, fraying of one screw and partial loosening of two other screws.There were signs of local septic flogose.This report involves one (1) 4.5mm ti va-lcp crvd condylar plate/6h/159mm/rt-ster.This is report 1 of 10 for (b)(4).This product complaint, (b)(4), is related to (b)(4).

• Brand Name: 4.5MM TI VA-LCP CRVD CONDYLAR PLATE/6H/159MM/RT-STER
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14731269
• MDR Text Key: 295033779
• Report Number: 8030965-2022-04101
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.124.406S
• Device Lot Number: 29P7909
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2022
• Initial Date FDA Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: VA LOCKSCR Ø5 OPTILINK TECHN SELF-TAP L4; VA LOCKSCR Ø5 OPTILINK TECHN SELF-TAP L4; VA LOCKSCR Ø5 OPTILINK TECHN SELF-TAP L4; VA LOCKSCR Ø5 OPTILINK TECHN SELF-TAP L8; VA LOCKSCR Ø5 OPTILINK TECHN SELF-TAP L8; VA LOCKSCR Ø5 OPTILINK TECHN SELF-TAP L8; VA LOCKSCR Ø5 OPTILINK TECHN SELF-TAP L8; VA LOCKSCR Ø5 OPTILINK TECHN SELF-TAP L8; VA LOCKSCR Ø5 OPTILINK TECHN SELF-TAP L9
• Patient Outcome(s): Required Intervention