MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-12-29 for ORTHOS TAPER PIN 1 PIN 50X1.3 841070 manufactured by Depuy France.
[2455443]
Patient revised for pain and reaction to orthosorb pin.
Patient Sequence No: 1, Text Type: D, B5
[9522364]
This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed.
Patient Sequence No: 1, Text Type: N, H10
[9830358]
The devices associated with this report were not returned. Review of the device history records and or a complaint database search was not possible as the product and lot codes required was unavailable. The investigation could not draw any conclusions regarding the reported event with the information available. Based on the inability to determine a root cause, the need for corrective action was not indicated. Depuy considers the investigation closed at this time. Should the product and / or additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2011-27349 |
| MDR Report Key | 2391761 |
| Report Source | 05 |
| Date Received | 2011-12-29 |
| Date of Report | 2011-11-09 |
| Date Mfgr Received | 2011-11-08 |
| Device Manufacturer Date | 2010-07-16 |
| Date Added to Maude | 2011-12-29 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KATHERINE SEPPA |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer G1 | DEPUY FRANCE |
| Manufacturer Street | 7 ALLEE IRENE JOLIOT CURIE |
| Manufacturer City | SAINT PRIEST CEDEX 69801 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 69801 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORTHOS TAPER PIN 1 PIN 50X1.3 |
| Generic Name | TRAUMA |
| Product Code | OVZ |
| Date Received | 2011-12-29 |
| Catalog Number | 841070 |
| Lot Number | 18110704 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY FRANCE |
| Manufacturer Address | 7 ALLEE IRENE JOLIOT CURIE SAINT PRIEST CEDEX 69801 FR 69801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-12-29 |