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 2018-06-07 for UNKNOWN ORTHOPEDIATRICS RESPONSE PEDICLE SCREW N/A manufactured by Orthopediatrics, Inc.
[110404712]
(b)(4). Concomitant medical devices: item: 00-1003-4001, response large set screw, lot: unknown, quantity: 19. Item: 00-1003-6001, response 5. 5 mm rod, 500 mm, lot: unknown, quantity: 2. Item: 00-1300-2630, response 5. 5/6. 0 polyaxial pedicle screw 6. 0 mm x 30 mm, lot: unknown, quantity: 9. Item: 00-1300-2635, response 5. 5/6. 0 polyaxial pedicle screw 6. 0 mm x 35 mm, lot: unknown, quantity: 3. Item: 00-1300-2740, response 5. 5/6. 0 polyaxial pedicle screw 7. 0 mm x 40 mm, lot: unknown. Item: 00-1300-3041, response adjustable cross connector small, lot: unknown. Item: 00-1300-5034, response 5. 5/6. 0 fixed cross connector, 34 mm, lot: unknown. Item: 00-1300-3735, response 5. 5/6. 0 polyaxial reduction pedicle screw 7, lot: unknown, quantity: 2. Item: 00-1300-3860, response 5. 5/6. 0 polyaxial reduction pedicle screw 8, lot: unknown. Item: 00-1300-3870, response 5. 5/6. 0 polyaxial reduction pedicle screw 8, lot: unknown. Item: 01-1300-3000, 1. 25 mm rounded guide wire 100 mm length, lot: unknown, quantity: 2. The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[110404713]
It was reported that following the placement of the response spine system, the patient underwent a revision procedure due to infection. A pedicle screw directly below an open wound was removed and replaced. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006460162-2018-00034 |
| MDR Report Key | 7579255 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-06-07 |
| Date of Report | 2018-09-20 |
| Date of Event | 2018-05-06 |
| Date Mfgr Received | 2018-05-11 |
| Date Added to Maude | 2018-06-07 |
| 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 | UNKNOWN ORTHOPEDIATRICS RESPONSE PEDICLE SCREW |
| Generic Name | UNKNOWN PEDICLE SCREW |
| Product Code | OSH |
| Date Received | 2018-06-07 |
| Model Number | N/A |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2018-06-07 |