MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05 report with the FDA on 2014-07-01 for SABER WDG I/F CAGE 11X11X25,5D 187225511 manufactured by Depuy Synthes Spine.
[4429158]
International affiliate in (b)(4) received an adverse incident report, incidence number(b)(4), was received from (b)(4) reporting: cage introduced to spinal space via inserter, upon impaction with mallet cage cracked but did not shatter. No injury to patient. Cage removed and a replacement inserted.
Patient Sequence No: 1, Text Type: D, B5
[12135397]
Additional narrative: the saber wedged cage was not returned for evaluation as it was discarded. Review of the device history record could not be conducted as the lot number is unknown. As such, without the lot number, a review of the manufacturing records cannot be completed. A 12-month review of the complaint trend analysis on the specific product code noted that there were no other reported complaints other than one for issues associated with cage breakage upon impaction. Without the return of the device, we are unable to confirm the reported issue or identify the root cause. No corrective action/preventive action (capa) is necessary at this time as we are unable to confirm the reported issue or identify the root cause. 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 | 1526439-2014-11653 |
| MDR Report Key | 3904201 |
| Report Source | 00,01,05 |
| Date Received | 2014-07-01 |
| Date of Report | 2014-06-09 |
| Date of Event | 2014-06-02 |
| Date Mfgr Received | 2014-06-09 |
| Date Added to Maude | 2014-07-01 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 WDG I/F CAGE 11X11X25,5D |
| Generic Name | SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM |
| Product Code | MCV |
| Date Received | 2014-07-01 |
| Catalog Number | 187225511 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2014-07-01 |