MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2020-02-10 for RESPONSE SET SCREW, LARGE N/A 00-1003-4001 manufactured by Orthopediatrics, Inc.
[185754948]
Reference: (b)(4). Report source: (b)(6). Customer has indicated that the product will not be returned to orthopediatrics for investigation as it remains implanted. The investigation is completed. 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.
Patient Sequence No: 1, Text Type: N, H10
[185754949]
It has been reported that following the placement of a spinal construct system, a distal set screw was noted to be loose. Patient underwent revision surgery on (b)(6) 2019 to remove set screw and corresponding pedicle screw. During the revision surgery, the surgeon identified a fractured pedicle screw.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006460162-2019-00064 |
| MDR Report Key | 9689063 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2020-02-10 |
| Date of Report | 2019-07-25 |
| Date Mfgr Received | 2019-07-18 |
| Date Added to Maude | 2020-02-10 |
| 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, INC |
| 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 SET SCREW, LARGE |
| Generic Name | PEDICLE SCREW SPINAL SYSTEM |
| Product Code | OSH |
| Date Received | 2020-02-10 |
| Model Number | N/A |
| Catalog Number | 00-1003-4001 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention; 2. Deathisabilit | 2020-02-10 |