MAUDE Adverse Event Report: MEDICREA INTERNATIONAL PASS LP; UNID ROD

Model Number B33226012

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Date 06/18/2020

Event Type  malfunction  

Event Description

Right unid rod is broken (implanted in (b)(6) 2016).Patient reported the break sounded like a gunshot and her back began to hurt.No other information on how it happened.She is otherwise not injured.

• Brand Name: PASS LP
• Type of Device: UNID ROD
• Manufacturer (Section D): MEDICREA INTERNATIONAL; 5389 route de strasbourg; 69140 rillieux la pape, ; FR
• Manufacturer (Section G): MEDICREA INTERNATIONAL; FR
• Manufacturer Contact: karine trogneux ; 5389 route de strasbourg; 69140 rillieux la pape, ; FR
• MDR Report Key: 10277810
• MDR Text Key: 201720344
• Report Number: 1000432246-2020-00005
• Device Sequence Number: 1
• Product Code: JDN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/19/2020,07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: B33226012
• Device Lot Number: 885CE220
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/19/2020
• Date Manufacturer Received: 06/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR