MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-09-11 for LOCKING CAP manufactured by .
[3113827]
A device report from (b)(6) indicated a surgeon in (b)(6) reported: pt implanted with posterior pedicle screw construct from l1 to l5 using pangea polyaxial screws for an l3 burst fracture. Pt developed pseudoarthrosis at the l4-l5 segment on an unk date. Pt was returned to the operating room on (b)(6) 2012. The construct was inspected and the head of the l4 screw on the right was disassociated from the bone screw which remained well fixed in the bone, the locking cap was attached to the head and rod. The inner set screws of locking caps on the l4 and l5 screws on the left were also loose. All screws and rods were removed. Pangea screw 04. 620. 645 was removed from the pt's right l4 pedicle. This is 14 of 22 reports.
Patient Sequence No: 1, Text Type: D, B5
[10175937]
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 | 2520274-2012-01848 |
| MDR Report Key | 2747304 |
| Report Source | 01,07 |
| Date Received | 2012-09-11 |
| Date of Report | 2012-08-14 |
| Date of Event | 2012-08-13 |
| Date Mfgr Received | 2012-08-14 |
| Date Added to Maude | 2012-09-18 |
| 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 | LOCKING CAP |
| Product Code | LYT |
| Date Received | 2012-09-11 |
| 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 | 2012-09-11 |