MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-06-18 for PEDICSCR MATRIX 5.5 POLYAXIAL ?5 PREASSM 04.632.540 manufactured by Synthes Brandywine.
[3446266]
It was reported that the polyaxial head was not fixed on the screw. When the doctor went to introduce the stem, he saw that the 3d head was not fixed on the screw. He replaced it and used it correctly. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10816945]
Synthes is submitting this report as a result of remediation activities related to fda warning letter dated february 2012. Device(s) listed in this report is (are) used for treatment, not diagnosis. Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr. Device is not distributed in the united states, but is similar to device marketed in the usa. The complained implants were analyzed for conformance to print specifications as well as the device history records were researched. The review revealed that the implants were manufactured in august and september 2011 according to the specifications and no abnormal findings were identified. Additional tests for functioning with the polyaxial head attached did not show any abnormalities. Based on the provided information, we suppose that the collet in the head was blocked in its upper position during the insertion and can lead to a detachment of the screw head. We are pleased to inform you that the design of the retaining sleeves 03. 632. 001 and 03. 632. 036, have been adapted to better hold the collet in lower question. In addition we recommend using the alignment tool 03. 632. 0007, for polyaxial screw heads to adjust the heads. This will also help to avoid a displacement of the collet.
Patient Sequence No: 1, Text Type: N, H10
[32213837]
Synthes is submitting this report as a result of remediation activities related to fda warning letter dated february 2012. Device(s) listed in this report is (are) used for treatment, not diagnosis. Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr. Awareness date was (b)(6) 2012. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2530088-2013-00957 |
| MDR Report Key | 3174936 |
| Report Source | 01,07 |
| Date Received | 2013-06-18 |
| Date of Report | 2012-03-13 |
| Date of Event | 2012-02-17 |
| Date Mfgr Received | 2014-08-06 |
| Device Manufacturer Date | 2011-08-30 |
| Date Added to Maude | 2013-09-12 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Manufacturer G1 | SYNTHES BRANDYWINE |
| Manufacturer Street | 1303 GOSHEN PARKWAY |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19380 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PEDICSCR MATRIX 5.5 POLYAXIAL ?5 PREASSM |
| Product Code | MCV |
| Date Received | 2013-06-18 |
| Catalog Number | 04.632.540 |
| Lot Number | 6752024 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES BRANDYWINE |
| Manufacturer Address | 1303 GOSHEN PARKWAY WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-06-18 |