MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-05-15 for INTEGRA MOZAIK MOLDABLE MORSELS - MID SIZE MSL075 manufactured by Integra Lifesciences Corp..
[3550555]
The product was found to have a hole in the inner sterile packaging. Another box was available for use in the surgery, so there was no delay in the surgery. There was no patient contact, injury or death. The suspected product was not implanted. Based on the investigative findings completed on (b)(4) 2013 and after a retrospective quality review, this case is being submitted as a medical device report as a reportable malfunction.
Patient Sequence No: 1, Text Type: D, B5
[10873116]
Integra has completed their internal investigation on (b)(4) 2013. The investigation results: a little hole was observed in the lid of the inner tray once the outer lid was lifted up. The inner tray was peeled off and there could be observed that the lid had been perforated. The hole was observed under microscope and it looked like it had been punctured by a needle or similar instrument. No further action was taken with the returned unit. The retained sample was reevaluated for this condition. The lid of the inner tray was found in acceptable condition. The dhr review of the lot #1121479 did not show any anomaly during it's packaging process that could be related to the reported condition. No similar complaints have been reported for this lot #1121479. (b)(4). Conclusion: the reported condition of "a hole in the inner sterile packaging" was confirmed. However, the root cause of this condition could not be determined. Future incidents of this nature will be documented for recurrence and trending purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2013-00008 |
| MDR Report Key | 3165037 |
| Report Source | 06 |
| Date Received | 2013-05-15 |
| Date of Report | 2013-05-15 |
| Date Mfgr Received | 2013-01-31 |
| Device Manufacturer Date | 2012-04-01 |
| Date Added to Maude | 2013-07-23 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ROWENA SALVADOR |
| Manufacturer Street | 315 ENTERPRISE DR. |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 8099362393 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTEGRA MOZAIK MOLDABLE MORSELS - MID SIZE |
| Generic Name | NA |
| Product Code | MDD |
| Date Received | 2013-05-15 |
| Catalog Number | MSL075 |
| Lot Number | 1121479 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORP. |
| Manufacturer Address | PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-15 |