MAUDE Adverse Event Report: PEGA MEDICAL INC THE LOCKING PEDIATRIC OSTEOTOMY PLATE SYSTEM (LOLLIPOP); M3 CONNECTOR FOR INFANT

Model Number	POP-M3I
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Malunion of Bone (4529)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The surgeon indicated no abnormal situation happen during surgery and he had no problem inserting the screw connector of the blade-plate assembly.
Event or Problem Description
Infant blade and plate implanted three weeks ago, detached in the patient.The connector that fixed the blade and plate got loosened.

• Brand Name: THE LOCKING PEDIATRIC OSTEOTOMY PLATE SYSTEM (LOLLIPOP)
• Common Device Name: M3 CONNECTOR FOR INFANT
• Manufacturer (Section D): PEGA MEDICAL INC; 1111 autoroute chomedey; laval,, quebec H7W5J 8; CA H7W5J8
• Manufacturer (Section G): PEGA MEDICAL INC; 1111 autoroute chomedey; laval, quebec H7W5J 8; CA H7W5J8
• Manufacturer Contact: enrique garcia ; 1111 autoroute chomedey; laval,, quebec H7W5J-8 ; CA H7W5J8
• MDR Report Key: 15510780
• Report Number: 3000327445-2022-00004
• Device Sequence Number: 6067923
• Product Code: KTT
• UDI-Device Identifier: 07540194006691
• UDI-Public: (01)07540194006691(10)B151-01
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K170704
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/16/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: POP-M3I
• Device Catalogue Number: POP-M3I
• Device Lot Number: B151-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2022
• Initial Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown