MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP RESPONSE 4.5/5.0 REDUCTION TOWER

Model Number 01-1600-9081

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/25/2020

Event Type  malfunction  

Manufacturer Narrative

Customer has indicated that the product is in process of being returned to orthopediatrics for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.(b)(4).

Event Description

It was reported that while securing the rod reduction tower to a 5.0x35 polyaxial 4.5/5.0 screw, the connecting side of the tower broke.Two small pieces of metal were removed from the surgical site, and the tower was no longer functional.We were able to use the second tower in the set to continue the procedure without delay.No adverse events have been reported as a result of the malfunction.

• Brand Name: RESPONSE 4.5/5.0 REDUCTION TOWER
• Type of Device: REDUCTION TOWER
• Manufacturer (Section D): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw, in
• Manufacturer (Section G): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw, in
• Manufacturer Contact: kriss anderson ; 2850 frontier drive; warsaw, in ; 2686379
• MDR Report Key: 10307788
• MDR Text Key: 199889600
• Report Number: 3006460162-2020-00083
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 01-1600-9081
• Device Catalogue Number: 01-1600-9081
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 10 YR
• Patient Weight: 36