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 2013-08-21 for WDG SABER I/F CAGE 9X9X25,5DEG 187025509 manufactured by Depuy Synthes Spine.
[3608603]
International affiliate reports the cage was broken during insertion/positioning. Another cage was available and was inserted without issue. There were no adverse consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
[4041334]
Additional information received from the affiliate indicated that the surgeon thinks that he had all of the broken pieces of the cage removed from the patient but is unsure.
Patient Sequence No: 1, Text Type: D, B5
[11014087]
A follow up report will be filed upon receipt of the device and completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[11400355]
.
Patient Sequence No: 1, Text Type: N, H10
[30489811]
Visual inspection of the returned cage noted that the device was fractured. Broken piece(s) of the cage were not returned as they were discarded. A review of the device history record found no discrepancies were observed during the manufacturing process. No issues were identified during the manufacturing and release of this product that could have been contributed to the problem reported by the customer. Review of product complaints for the cage and its product family found no significant trends. The root cause of the cage breakage cannot positively be determined. However, as noted in the accompanying instructions for use, correct selection and handling of the implant is extremely important. Polymer/carbon fiber implants are designed to support physiologic loads. Excessive torque, when applied to long-handle insertion tools, can cause splitting or fracture of the polymer/carbon-fiber implants. When a polymer/carbon-fiber implant is impacted or hammered into place, the broad surface of the insertion tool should be carefully seated fully against the implant. Impaction forces applied directly to a small surface of the implant could cause fracture of the implant. No corrective action/preventive action is required as there has been no issue identified in the manufacturing or release of the device, and there has been no systematic trend. Therefore, this complaint will be closed with no further action required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1526439-2013-24652 |
| MDR Report Key | 3300563 |
| Report Source | 01,05,07 |
| Date Received | 2013-08-21 |
| Date of Report | 2013-08-12 |
| Date of Event | 2013-08-09 |
| Date Mfgr Received | 2013-08-12 |
| Device Manufacturer Date | 2009-08-21 |
| Date Added to Maude | 2013-08-21 |
| 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 | BETH BECOTTE |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088283575 |
| Manufacturer G1 | MEDOS INTERNATIONAL SARL |
| Manufacturer Street | 38 CHEMIN BLANC |
| Manufacturer City | LELOCLE CH-2400 |
| Manufacturer Country | US |
| Manufacturer Postal Code | CH-2400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WDG SABER I/F CAGE 9X9X25,5DEG |
| Generic Name | SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM |
| Product Code | MCV |
| Date Received | 2013-08-21 |
| Returned To Mfg | 2013-10-11 |
| Catalog Number | 187025509 |
| Lot Number | AKKBDC |
| 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 | 2013-08-21 |