EIGHT-PLATE GUIDED GROWTH SYSTEM GP632

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-08-04 for EIGHT-PLATE GUIDED GROWTH SYSTEM GP632 manufactured by Orthofix Inc.

Event Text Entries

[2385324] Information provided states patient was implanted bilateral with 2 quad plates (gpq800) and eight (8) screws (gp632) on (b)(6) 2010. X-rays taken on (b)(6) 2011 shows that 2 distal screws in each plate broke during treatment. Two plates and the broken screws were removed and replaced.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3008524126-2011-00025
• MDR Report Key: 2249455
• Report Source: 07
• Date Received: 2011-08-04
• Date of Report: 2011-08-04
• Date of Event: 2011-06-01
• Date Mfgr Received: 2011-06-17
• Device Manufacturer Date: 2008-06-01
• Date Added to Maude: 2012-01-05
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: YOLANDA THOMPSON
• Manufacturer Street: 3451 PLANO PARKWAY
• Manufacturer City: LEWISVILLE TX 75056
• Manufacturer Country: US
• Manufacturer Postal: 75056
• Manufacturer Phone: 2149372291
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: EIGHT-PLATE GUIDED GROWTH SYSTEM
• Generic Name: BONE SCREW, 32MM, SOLID
• Product Code: OBT
• Date Received: 2011-08-04
• Returned To Mfg: 2011-07-22
• Model Number: GP632
• Lot Number: 17484 (4)
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ORTHOFIX INC
• Manufacturer Address: LEWISVILLE TX US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2011-08-04