MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-10 for 7807-001-01 manufactured by Zimmer Biomet Spine Inc..
[67111628]
Patient Sequence No: 1, Text Type: N, H10
[67111629]
Mini hohmann retractor was being used to retract; the tip of the mini hohmann broke off in the acetabulum.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6321715 |
| MDR Report Key | 6321715 |
| Date Received | 2017-02-10 |
| Date of Report | 2017-01-11 |
| Date of Event | 2017-01-09 |
| Report Date | 2017-01-11 |
| Date Reported to FDA | 2017-01-11 |
| Date Reported to Mfgr | 2017-01-11 |
| Date Added to Maude | 2017-02-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | RETRACTOR |
| Product Code | HXO |
| Date Received | 2017-02-10 |
| Model Number | 7807-001-01 |
| ID Number | 003SIUE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET SPINE INC. |
| Manufacturer Address | 310 INTERLOCKEN PKWY. STE 120 BROOMFIELD CO 80021 US 80021 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-02-10 |