MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-03-21 for FEMORAL/TIBIAL CHECKPOINT KIT -(STERILE) 111645 manufactured by Mako Surgical Corp..
[139448348]
As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical. A supplemental report will be submitted when additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[139448349]
After completion of case, the nurse count of checkpoints was completed saying that all checkpoints and sponges were out. Unfortunately upon post-op x-ray, it was discovered that both femoral and tibial checkpoints were still in patient. Patient was called back the next day to have them removed by dr. (b)(6). Case type: tka.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005985723-2019-00255 |
| MDR Report Key | 8440073 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-03-21 |
| Date of Report | 2019-06-11 |
| Date of Event | 2019-02-27 |
| Date Mfgr Received | 2019-05-30 |
| Date Added to Maude | 2019-03-21 |
| 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 | MR. BETHANY HINSON |
| Manufacturer Street | 2555 DAVIE ROAD |
| Manufacturer City | FORT LAUDERDALE FL 33317 |
| Manufacturer Country | US |
| Manufacturer Postal | 33317 |
| Manufacturer Phone | 9546280700 |
| Manufacturer G1 | MAKO SURGICAL CORP. |
| Manufacturer Street | 2555 DAVIE ROAD |
| Manufacturer City | FORT LAUDERDALE FL 33317 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33317 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FEMORAL/TIBIAL CHECKPOINT KIT -(STERILE) |
| Generic Name | STEREOTAXIC DEVICE, ROBOTICS |
| Product Code | OLO |
| Date Received | 2019-03-21 |
| Catalog Number | 111645 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAKO SURGICAL CORP. |
| Manufacturer Address | 2555 DAVIE ROAD FORT LAUDERDALE FL 33317 US 33317 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2019-03-21 |