MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH LUMBAR PEDICLE PROBE, ST

Model Number	299704115
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2019, the expedium verse pedicle probe (straight lumbar) broke off 10 mm inside the patients vertebral body.Broken fragments where generated, it was difficult to removed that's why it was retained and kept in the body.The procedure was completed successfully.The patient status was unknown.This complaint involves one (1) device.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Visual examination at the macroscopic level revealed that the fracture was located at 20mm from the probe¿s distal tip.The second half of the probe¿s tip was not returned.The x-ray image was reviewed, and it was noted that the piece of the probe was embedded in the patient¿s body.The fracture analysis report reveals plastic deformation at the edges and torsional shear markings following a circular pattern.This suggests the fracture tip underwent a quasi-static overload torsional shear failure.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.A definitive root cause for the probe¿s distal tip becoming fractured cannot be positively determined.However, the fracture analysis report suggests the fracture tip underwent a quasi-static overload torsional shear failure.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LUMBAR PEDICLE PROBE, ST
• Common Device Name: PROBE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9125372
• Report Number: 1526439-2019-52163
• Device Sequence Number: 2820020
• Product Code: HXB
• UDI-Device Identifier: 10705034467238
• UDI-Public: (01)10705034467238
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2019

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: 299704115
• Device Catalogue Number: 299704115
• Device Lot Number: GB72331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 10/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 54 YR
• Patient Weight: 131