MAUDE Adverse Event Report: BIOMET ORTHOPEDICS DYNAMIC COMP PLATE SS 9 HOLE; CERCLAGE, FIXATION

Model Number N/A

Device Problem Bent (1059)

Patient Problem No Code Available (3191)

Event Date 04/11/2014

Event Type  Injury  

Event Description

It was reported patient underwent an initial procedure on (b)(6) 2013.A review of post-op radiographs revealed a bent plate.Subsequently, patient was revised on (b)(6) 2014.The plate was removed and replaced.Patient underwent another revision procedure on (b)(6) 2014 due to a bent plate.The plate was removed and replaced with a competitor plate.

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 2 states, "bending or fracture of the implant." evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be sent to the fda.

Manufacturer Narrative

Examination of returned device found no evidence of product non-conformance.Dimensional evaluation found component to be within appropriate design specification.

• Brand Name: DYNAMIC COMP PLATE SS 9 HOLE
• Type of Device: CERCLAGE, FIXATION
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: amanda zajicek ; 56 e. bell drive; warsaw, IN 46582 ; 5743726782
• MDR Report Key: 3851985
• MDR Text Key: 4684083
• Report Number: 0001825034-2014-05276
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK982545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 350819
• Device Lot Number: 646840
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention