MUST PEDICLE SCREW SYSTEM - SCREW DRIVER

Report

• Report Number: 3005180920-2014-00088
• Event Type: Malfunction
• Date Received: July 24, 2014
• Manufacturer: MEDACTA INTERNATIONAL, SA
• Product Code: LZO
• Report Source: Manufacturer report

Narratives

Additional Manufacturer Narrative · 1

FROM THE DOCUMENT REVIEW OF THE LOT INVOLVED (1112874- (B)(4) ITEMS PRODUCED) NO ANOMALIES WERE FOUND. IT IS THE FIRST BREAKAGE OF THIS CODE AND LOT. FURTHER INVESTIGATION IS ON GOING AND A FOLLOW UP WILL BE SUBMITTED IN CASE OF NEW OUTCOMES.

Description of Event or Problem · 1

IMP - (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
432844	MUST PEDICLE SCREW SYSTEM - SCREW DRIVER	REUSABLE SURGICAL INSTRUMENT FOR SPINE	LZO	MEDACTA INTERNATIONAL, SA

Patients

Seq	Age	Sex	Outcome	Treatment
1

Terms

Patient problem · 1

• No Known Impact Or Consequence To Patient

Product problems · 1

• Break

Source type · 1

• Other

Type of report · 1

• Initial submission