MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2018-12-14 for RESPONSE SPINE SET SCREW N/A UNKNOWN manufactured by Orthopediatrics, Inc.
[130487618]
(b)(4). Customer has indicated that the product will not be returned to orthopediatrics for investigation as it is still implanted. The event was confirmed via communication with the surgeon, however item and lot numbers were never received. Dhr review was unable to be performed as the lot number of the device involved in the event is unknown. Root cause was unable to be determined. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Orthopediatrics will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
[130487619]
It has been reported that several months following the placement of a response spine system, a set screw was discovered to be loose. No adverse events have been reported as a result of the malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006460162-2018-00075 |
| MDR Report Key | 8166128 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-12-14 |
| Date of Report | 2018-12-14 |
| Date Mfgr Received | 2018-11-15 |
| Date Added to Maude | 2018-12-14 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | LEIGH JESSOP |
| Manufacturer Street | 2850 FRONTIER DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5742670872 |
| Manufacturer G1 | ORTHOPEDIATRICS, INC |
| Manufacturer Street | 2850 FRONTIER DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESPONSE SPINE SET SCREW |
| Generic Name | PEDICLE SCREW SPINAL SYSTEM |
| Product Code | OSH |
| Date Received | 2018-12-14 |
| Model Number | N/A |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHOPEDIATRICS, INC |
| Manufacturer Address | 2850 FRONTIER DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-14 |