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 2014-08-11 for SABER CAGE 11*10*25 187225010 manufactured by Depuy Synthes Spine.
[4709729]
International affiliate reports that when the surgeon wanted to fill the cage with the patient's bone, the bone piece was too big. He therefore used a hammer to insert the bone piece. The cage cracked where the implant driver is supposed to be screwed and another cage was used to complete the surgery. The difficulty resulted in a five to ten minute delay to the procedure. No patient was impact was reported.
Patient Sequence No: 1, Text Type: D, B5
[11954465]
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
[27532599]
The 11x10x25mm saber cage was returned for evaluation. Visual inspection found fractures on both the left and right hand sides of the threaded hole. 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 12 month review of the complaint trend analysis for the saber cage was performed on the cage? S specific product code from the complaint as the change in dimensions across the product family change the fracture profile for the cage. This analysis found no related complaints. The root cause cannot be determined from the sample and information provided. According to the original event description, a larger-than-average piece of bone was used to fill the cage. This piece was inserted via a hammer. A potential root cause is force applied to a bone fragment too large to fit inside of the cage via the insertion method used. The force of the hammer transferred to the cage through the bone fragment, causing the fracture in the cage. No corrective and preventive action (capa) is necessary at this time as there has been no issue identified in the manufacturing or release of this device. Therefore, this complaint 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 | 1526439-2014-11755 |
| MDR Report Key | 3999320 |
| Report Source | 01,05,07 |
| Date Received | 2014-08-11 |
| Date of Report | 2014-07-15 |
| Date of Event | 2014-07-06 |
| Date Mfgr Received | 2014-08-25 |
| Device Manufacturer Date | 2009-11-27 |
| Date Added to Maude | 2014-08-11 |
| 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 | SABER CAGE 11*10*25 |
| Generic Name | SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM |
| Product Code | MCV |
| Date Received | 2014-08-11 |
| Returned To Mfg | 2014-08-06 |
| Catalog Number | 187225010 |
| Lot Number | AKNB2J |
| 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 | 2014-08-11 |