MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-02-08 for RONGEUR,UNKNOWN XXX-RUGGLES RONGEUR, manufactured by Integra York, Pa Inc..
[135514531]
It is unknown if the device involved will be returned to the manufacturer for evaluation. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[135514532]
Sus voluntary event report foi for manufacturers (mw5082255) was received on 14jan2019 with the following information: on (b)(6) 2018, a surgical tech noted that a screw of the 260-504 ruggles redmond was missing (measured about 5mm in diameter and several 8mm in length) during a hip arthroplasty surgery. An xray was taken to confirm the screw had fallen into the posterior soft tissues. The device was in contact with the patient. There is no information provided regarding patient injury or death alleged and delay in the surgery. Additional information has been requested but no clinical information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2019-00018 |
| MDR Report Key | 8319939 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-02-08 |
| Date of Report | 2019-01-14 |
| Date of Event | 2018-12-12 |
| Date Mfgr Received | 2019-02-14 |
| Date Added to Maude | 2019-02-08 |
| 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 | USER KIMBERLY SHELLY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA YORK, PA INC. |
| Manufacturer Street | 589 DAVIES DRIVE |
| Manufacturer City | YORK PA 17402 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 17402 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RONGEUR,UNKNOWN |
| Generic Name | N/A |
| Product Code | HTX |
| Date Received | 2019-02-08 |
| Catalog Number | XXX-RUGGLES RONGEUR, |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | 589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-08 |