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

Model Number 299704115

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/05/2019

Event Type  Injury  

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 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.

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
• Type of Device: PROBE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 9125372
• MDR Text Key: 162295467
• Report Number: 1526439-2019-52163
• Device Sequence Number: 1
• Product Code: HXB
• UDI-Device Identifier: 10705034467238
• UDI-Public: (01)10705034467238
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/04/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 131