MAUDE Adverse Event Report: SPINEWAY SA MONT BLANC; PEDICLE PROBE, THORACIC, STRAIGHT

Catalog Number	229PPTS1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
During surgery a pedicle probe broke, and the tip remained in the patient's bone.The material of the probe is not intended to be implanted and thus, the risk of serious deterioration in the state of health of the patient for a long-term in unknown.

• Brand Name: MONT BLANC
• Common Device Name: PEDICLE PROBE, THORACIC, STRAIGHT
• Manufacturer (Section D): SPINEWAY SA; 7 allée du moulin berger; ecully, 69130 ; FR 69130
• Manufacturer Contact: héloïse macaire ; 7 allée du moulin berger; ecully, 69130 ; FR 69130
• MDR Report Key: 13966290
• Report Number: 3010758686-2022-00002
• Device Sequence Number: 19901397
• Product Code: LXH
• UDI-Device Identifier: 03663422603319
• UDI-Public: 3663422603319
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K161387
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 229PPTS1
• Device Lot Number: 2171095
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2022
• Initial Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown