MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2017-10-25 for OMNIPORE SURGICAL IMPLANT - CRANIOTOMY GAP WEDGE OP82011 manufactured by Matrix Surgical Usa.
[90874992]
Device evaluation: distributor returned devices for exchange on 12-oct-2017; the reported non-conformity was confirmed. A review of the manufacturing records showed no anomalies. A review of previous complaint history shows that no similar complaints have been reported. All available devices in inventory manufactured during the same timeframe were visually inspected for unsealed pouches. No additional impacted devices were identified. Potential contributing manufacturing factors have been considered and corrective actions have been initiated. A good faith effort will be made to inspect all remaining inventory for this issue prior to shipment. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[90874993]
On september 27, 2017, it was reported by our contract distributor (b)(4) in (b)(4) that the outer pouch for part craniotomy gap wedges (op82011); lot 00855421005727 018141116 was not sealed. No patient or end user involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009383407-2017-00002 |
| MDR Report Key | 6977258 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2017-10-25 |
| Date of Report | 2017-10-24 |
| Date Mfgr Received | 2017-09-27 |
| Device Manufacturer Date | 2016-11-22 |
| Date Added to Maude | 2017-10-25 |
| 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 | MS VICKI CLOUTIER |
| Manufacturer Street | 4025 WELCOM ALL ROAD SUITE 120 |
| Manufacturer City | ATLANTA GA 30349 |
| Manufacturer Country | US |
| Manufacturer Postal | 30349 |
| Manufacturer Phone | 9513260131 |
| Manufacturer G1 | MATRIX SURGICAL USA |
| Manufacturer Street | 4025 WELCOME ALL ROAD SUITE 120 |
| Manufacturer City | ATLANTA GA 30349 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30349 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OMNIPORE SURGICAL IMPLANT - CRANIOTOMY GAP WEDGE |
| Generic Name | CRANIOTOMY GAP WEDGE |
| Product Code | KKY |
| Date Received | 2017-10-25 |
| Returned To Mfg | 2017-10-12 |
| Model Number | OP82011 |
| Catalog Number | OP82011 |
| Lot Number | 00855421005727 018141116 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MATRIX SURGICAL USA |
| Manufacturer Address | 4025 WELCOME ALL ROAD SUITE 120 ATLANTA GA 30349 US 30349 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-25 |