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 2018-10-29 for RESPONSE UNIAXIAL PEDICLE SCREW N/A 00-1300-3650 manufactured by Orthopediatrics, Inc.
[125382306]
Reference: (b)(4). Complaint sample was evaluated and the reported event was confirmed. Visual inspection confirmed that the screw fractured. Investigation of the dhr did not reveal any process deviations or indications of manufacturing variations that would contribute to the observed failure mode. The screw was made to specification, there had been no recent design changes to the screw shaft, and there are no other complaints related to this part number. The root cause was unable to be determined. "loss of fixation or implant breakage attributable to delayed or non-union" is a known adverse effect stated in the device ifu. 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
[125382307]
It was reported that following the placement of a response spine construct, a screw was found to be fractured at a one-year follow-up. The surgeon believes that pseudarthrosis caused the fracture of the screw. The patient underwent a revision procedure to replace the fractured screw. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006460162-2018-00069 |
| MDR Report Key | 8016746 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-10-29 |
| Date of Report | 2018-10-28 |
| Date Mfgr Received | 2017-05-23 |
| Device Manufacturer Date | 2018-05-29 |
| Date Added to Maude | 2018-10-29 |
| 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 | 5172670872 |
| 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 UNIAXIAL PEDICLE SCREW |
| Generic Name | PEDICLE SCREW SPINAL SYSTEM |
| Product Code | OSH |
| Date Received | 2018-10-29 |
| Returned To Mfg | 2017-06-08 |
| Model Number | N/A |
| Catalog Number | 00-1300-3650 |
| Lot Number | 041818-E |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 1. Required No Informationntervention | 2018-10-29 |