MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2014-06-04 for 2G WEDGE I/F CAGE 11X10X25, 5 187225510 manufactured by Depuy Synthes Spine.
[4661353]
International affiliate received adverse incident report from mhra reporting that a saber cage was mounted on inserter and placed in spinal space. When using a mallet to push the cage into the space, the cage splintered into seven pieces. Details of injury (to patient, carer or healthcare professional): none. Action taken (includes any action by patient, carer or healthcare professional, or by the manufacturer or supplier): all pieces removed and placed together to check all accounted for. Another cage was then inserted into the spinal space without incident.
Patient Sequence No: 1, Text Type: D, B5
[11804463]
Additional narrative: a follow up report will be filed upon completion of the investigation. 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
[20178662]
The 2g eedge i/f cage, 11x10x25 was returned for evaluation. Visual inspection revealed that the cage had fractured into 7 segments. A review of the device history record (dhr) identified no issues during the manufacturing and release of this product that could have contributed to the problem reported by the customer. The product was released accomplishing all quality requirements. A twelve month complaint trend analysis was conducted and the device family has been reviewed as a part of post market surveillance activities with no design actions required as a result. The root cause cannot be positively determined. However, the accompanying instructions for use (ifu) indicate that excessive torque on the implant can cause splitting or fracture. Additionally, the cage should be fully seated against the inserter or impaction forces could be applied to a small surface of the implant causing fracture. No corrective action/preventive action (capa) is necessary at this time as there have been no issues identified in the release of this implant that could have contributed to the problem reported by the customer. Therefore, 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 | 1526439-2014-11559 |
| MDR Report Key | 3849015 |
| Report Source | 01,05,07 |
| Date Received | 2014-06-04 |
| Date of Report | 2014-05-15 |
| Date of Event | 2014-05-09 |
| Date Mfgr Received | 2014-06-24 |
| Device Manufacturer Date | 2014-02-11 |
| Date Added to Maude | 2014-06-04 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | ANITA BARNICK |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088283583 |
| Manufacturer G1 | MEDOS INTERNATIONAL SARL |
| Manufacturer Street | 38 CHEMIN BLANC |
| Manufacturer City | LELOCLE CH-2400 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH-2400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 2G WEDGE I/F CAGE 11X10X25, 5 |
| Generic Name | SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM |
| Product Code | MCV |
| Date Received | 2014-06-04 |
| Returned To Mfg | 2014-05-29 |
| Catalog Number | 187225510 |
| Lot Number | ARBBR9 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES SPINE |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-04 |