MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-04 for BUDDE HALO RETRACTOR MODIFIED A1040A manufactured by Integra Lifesciences Corporation Oh/usa.
[35351167]
It was reported that the cable of one arm was broken and needs to be replaced. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[54906591]
Integra has completed their internal investigation on 07/28/2016. The investigation included: methods: evaluation of actual device. Review of device history records. Review of complaint history. Results: evaluation of device: the cable of retractor arm is broken, it needs to be replaced. The device in question was manufactured on december 31, 2008. A two year lookback in complaint system for this reported failure and or related to "arm is broken " for this product id shows that 3 complaints were received including this case. No new design or manufacturing trends have been identified. This issue will be monitored. In summary, the end user's reason for return was verified however, no root cause could be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004608878-2015-00324 |
| MDR Report Key | 5342333 |
| Date Received | 2016-01-04 |
| Date of Report | 2015-12-10 |
| Date Mfgr Received | 2016-07-28 |
| Date Added to Maude | 2016-01-04 |
| 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 ROWENA BUNUAN |
| 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 MODIFIED |
| Generic Name | RADIOLUCENT SYSTEMS |
| Product Code | GZT |
| Date Received | 2016-01-04 |
| Returned To Mfg | 2016-07-28 |
| Catalog Number | A1040A |
| Lot Number | 089 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2016-01-04 |