MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-23 for UNK - CABLE/WIRE ACCESSORIES: ORTHOPAEDIC CABLE manufactured by Wrights Lane Synthes Usa Products Llc.
[184710841]
This report is for an unk - cable/ wire accessories: orthopaedic cable/ unknown lot. Part and lot numbers are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/ investigation. Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[184710842]
It was reported that on an unknown date, the patient had plate and screws implanted ten years ago that seem to be reacting to. The patient's doctor said it may be a nickel allergy but believed it was titanium. The patient wants to know what the following implants are made up of. Titanium implants ticp do not contain nickel. Stainless steel implants do contain nickel. There was no surgery delay reported and patient outcome unknown. This complaint involves nine (9) devices. This is 8 of 9 for report (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01478 |
| MDR Report Key | 9868250 |
| Report Source | CONSUMER |
| Date Received | 2020-03-23 |
| Date of Report | 2020-02-24 |
| Date Mfgr Received | 2020-02-24 |
| Date Added to Maude | 2020-03-23 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK - CABLE/WIRE ACCESSORIES: ORTHOPAEDIC CABLE |
| Generic Name | WIRE, SURGICAL |
| Product Code | LRN |
| Date Received | 2020-03-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHTS LANE SYNTHES USA PRODUCTS LLC |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-23 |