MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-23 for BONE PIN, 3.2MM X 110MM, STERILE 2 PACK 143110 manufactured by Mako Surgical Corp..
[184471698]
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
[184471699]
In (b)(4) while doing a pka case with doctor the tip of the pin broke. Update: "was the patient in the o. R. At the time of event? Yes. Was the patient under anesthesia? Yes. Did the device break in the patient? Yes. Were all pieces removed? Most probably. If so, how was this verified? Visually. If not, why not? Might be that a small part of the tip remained. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005985723-2020-00168 |
| MDR Report Key | 9865013 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-02-26 |
| Date Mfgr Received | 2020-02-26 |
| 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 | MR. ALESSANDRA CHAVEZ |
| 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 | BONE PIN, 3.2MM X 110MM, STERILE 2 PACK |
| Generic Name | STEREOTAXIC DEVICE, ROBOTICS |
| Product Code | OLO |
| Date Received | 2020-03-23 |
| Model Number | 143110 |
| Catalog Number | 143110 |
| Lot Number | W50726-2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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. Hospitalization | 2020-03-23 |