MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-07-19 for CAP manufactured by .
[2838285]
A device report from (b)(6) indicated a hospital in (b)(6) reported: in (b)(6) 2009, patient was treated for degenerative scoliosis with click-x fusion levels t12 to s1 with a screw at all pedicles, rods and two cross links. Patient's symptoms returned and an x-ray on an unknown date showed a non-union at l5-s1, where the rod pulled out of a pedicle screw. On one side. Patient was returned to the operating room on (b)(6) 2012, all hardware was removed. During hardware removal it was determined the non-union was at level l3-l4. It is not known if new hardware was implanted. No further information available. This is 10 of 18 reports for this event.
Patient Sequence No: 1, Text Type: D, B5
[9988032]
Without a lot number the device history records review could not be completed. The investigation could not be completed, no conclusion could be drawn, as no product was received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2012-01294 |
| MDR Report Key | 2668447 |
| Report Source | 01,07 |
| Date Received | 2012-07-19 |
| Date of Report | 2012-06-21 |
| Date of Event | 2012-06-20 |
| Date Mfgr Received | 2012-06-21 |
| Date Added to Maude | 2012-07-26 |
| 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 | MS SHERRY LAING |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | CAP |
| Product Code | LYT |
| Date Received | 2012-07-19 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-07-19 |