MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-06-07 for BUDDE HALO RETRACTOR A1040 manufactured by Integra Lifesciences Corporation Oh/usa.
[110462863]
The device was returned for evaluation. The compression ball was oval on the id preventing smooth movement of the bar through the ball. As per dhr review, build records were reviewed and no issues were found. The reported complaint has been confirmed. Root cause: the spheres have been compressed out of round, either by torqueing the item down while it was not properly seated or the ball has been over-torqued.
Patient Sequence No: 1, Text Type: N, H10
[110462864]
A customer reported that on an unspecified date, they received one (b)(4) compression ball from the a1040 budde halo retractor and it was noted to be "elliptically shaped not round". It does not allow the rod to pass through as it should. There was no patient prepped for surgery. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004608878-2018-00099 |
| MDR Report Key | 7577933 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-06-07 |
| Date of Report | 2018-04-10 |
| Date Mfgr Received | 2018-05-30 |
| Device Manufacturer Date | 2017-07-26 |
| Date Added to Maude | 2018-06-07 |
| 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 LIFESCIENCES CORPORATION OH/USA |
| Manufacturer Street | 4900 CHARLEMAR DRIVE |
| Manufacturer City | CINCINNATI OH 45227 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 45227 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BUDDE HALO RETRACTOR |
| Generic Name | N/A |
| Product Code | GZT |
| Date Received | 2018-06-07 |
| Returned To Mfg | 2018-05-22 |
| Catalog Number | A1040 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION OH/USA |
| Manufacturer Address | 4900 CHARLEMAR DRIVE 4900 CHARLEMAR DRIVE CINCINNATI OH 45227 US 45227 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-07 |