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 2020-02-26 for RESPONSE 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 45MM N/A 00-1300-0745 manufactured by Orthopediatrics, Corp.
[185788306]
Reference: (b)(4). Concomitant product: item number: 00-1003-4001, response large set screw, lot number: m56976-b, item number: 00-1003-4001, response large set screw, lot number: m55906-a, item number: 00-1300-0745, response 5. 5/6. 0 uniaxial pedicle screw 7. 0mm x 45mm, lot number: 041824-e, item number: unknown, unknown response 6. 0 cocr rod, lot number: unknown, item number: unknown, unknown response 6. 0 cocr rod, lot number: unknown. Multiple mdr reports were filed for this event, please see associated reports: 3006460612-2019-00084, 3006460612-2019-00085, and 3006460612-2019-00087.
Patient Sequence No: 1, Text Type: N, H10
[185788307]
It has been reported that following the placement of a response spinal construct, the patient underwent a revision due to rod fracture and disengagement. During the revision it was noted that two pedicle screws were replaced due to wear. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006460162-2019-00086 |
| MDR Report Key | 9756062 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-26 |
| Date of Event | 2019-11-06 |
| Date Mfgr Received | 2019-11-20 |
| Device Manufacturer Date | 2015-06-05 |
| Date Added to Maude | 2020-02-26 |
| 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 | 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 2670872 |
| Manufacturer G1 | ORTHOPEDIATRICS, CORP |
| Manufacturer Street | 2850 FRONTIER DRIVE |
| Manufacturer City | WARSAW, IN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESPONSE 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 45MM |
| Generic Name | PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS |
| Product Code | OSH |
| Date Received | 2020-02-26 |
| Model Number | N/A |
| Catalog Number | 00-1300-0745 |
| Lot Number | 042938-E |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHOPEDIATRICS, CORP |
| Manufacturer Address | 2850 FRONTIER DRIVE WARSAW, IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-26 |