MAUDE Adverse Event Report: PARAGON 28, INC. GORILLA PLATING SYSTEM; FIBULAR PLATE, CLUSTER, 9-HOLE, ANATOMICAL, RIGHT

Model Number P53-203-R009

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Insufficient Information (4580)

Event Date 05/04/2021

Event Type  malfunction  

Manufacturer Narrative

The implant was not used however, this malfunction is related to a violation of fda regulation.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.

Event Description

Mislabeling of product on temporary packaging.Part p53-203-r009 was labelled as p53-102-l003.

Manufacturer Narrative

Visual evaluation of the product confirms the failure mode of the product being mislabeled.The implant was not used as it was a replenishment order when the complaint initiator noticed the problem.However, this malfunction is related to a violation of fda regulation.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.

• Brand Name: GORILLA PLATING SYSTEM
• Type of Device: FIBULAR PLATE, CLUSTER, 9-HOLE, ANATOMICAL, RIGHT
• Manufacturer (Section D): PARAGON 28, INC.; 14445 grasslands dr.; englewood CO 80112
• MDR Report Key: 11839484
• MDR Text Key: 263433443
• Report Number: 3008650117-2021-00091
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K190365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P53-203-R009
• Device Catalogue Number: P53-203-R009
• Device Lot Number: CP2103184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Initial Date Manufacturer Received: 05/04/2021
• Initial Date FDA Received: 05/18/2021
• Supplement Dates Manufacturer Received: 05/04/2021
• Supplement Dates FDA Received: 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 31 YR