MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-01-06 for RESPONSE 5.5 SPINE SYSTEM 00-1003-4355 manufactured by Orthopediatrics Corp..
[64067442]
Initial report filed prior to scheduled revision surgery. Return of fractured screws for evaluation has been requested. If devices are returned, they will be evaluated and a follow up report submitted.
Patient Sequence No: 1, Text Type: N, H10
[64067443]
The proximal portion of both pedicle screws broke off. The screws were located at the bottom of the construct at l3 as part of a t5-l3 fusion. Original date of surgery was (b)(6) 2014.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006460162-2016-04355 |
| MDR Report Key | 6229482 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-01-06 |
| Date of Report | 2016-12-07 |
| Date of Event | 2016-12-07 |
| Date Mfgr Received | 2016-12-07 |
| Date Added to Maude | 2017-01-06 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MARK FOX |
| Manufacturer Street | 2850 FRONTIER DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5742686379 |
| Manufacturer G1 | ORTHOPEDIATRICS CORP. |
| 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 5.5 SPINE SYSTEM |
| Generic Name | PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS |
| Product Code | OSH |
| Date Received | 2017-01-06 |
| Catalog Number | 00-1003-4355 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHOPEDIATRICS CORP. |
| Manufacturer Address | 2850 FRONTIER DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-01-06 |