MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-09-26 for LUMBAR PEDICLE PROBE, ST 299704115 manufactured by Medos International Sàrl Ch.
[162295467]
(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.
Patient Sequence No: 1, Text Type: N, H10
[162295468]
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.
Patient Sequence No: 1, Text Type: D, B5
[179577728]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1526439-2019-52163 |
| MDR Report Key | 9125372 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-09-26 |
| Date of Report | 2019-09-05 |
| Date of Event | 2019-09-05 |
| Date Mfgr Received | 2019-10-29 |
| Device Manufacturer Date | 2016-01-04 |
| Date Added to Maude | 2019-09-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | DEPUY SYNTHES SPINE |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUMBAR PEDICLE PROBE, ST |
| Generic Name | PROBE |
| Product Code | HXB |
| Date Received | 2019-09-26 |
| Returned To Mfg | 2019-09-24 |
| Model Number | 299704115 |
| Catalog Number | 299704115 |
| Lot Number | GB72331 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDOS INTERNATIONAL SàRL CH |
| Manufacturer Address | CHEMIN-BLANC 38 LE LOCLE 02400 SZ 02400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-09-26 |