MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-01-31 for PROBE FOR COMPARTMENTAL PRESSURE MONITORING SYSTEM 530.412 manufactured by Synthes Monument.
[3224230]
It was reported while using the probe for compartmental pressure monitoring system during a tibia plateau fracture procedure, they received a probe malfunction error. No injuries or medical intervention was reported. No delay in surgery was reported.
Patient Sequence No: 1, Text Type: D, B5
[10370982]
Device was used for diagnostic. Device is an instrument and is not implanted/explanted. The investigation could not be completed; no conclusion could be drawn, as no product was received. A review of the device history records has been requested.
Patient Sequence No: 1, Text Type: N, H10
[10550556]
A device history record review was conducted. The lot was processed per specification requirements as noted in the certificate of compliance and inspected and accepted to the synthes inspection sheet. There were no mrrs, ncrs, or complaint-related issues with this lot.
Patient Sequence No: 1, Text Type: N, H10
[31698543]
A service history of the past six months has been reviewed. No service history review can be performed. The item has not previously been sent in for service. There is no information relevant to the current complained issue. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[34452670]
Device used for diagnosis, not treatment. Subject device has been received and is currently in the evaluation process. Investigation is ongoing; no conclusion could be drawn.
Patient Sequence No: 1, Text Type: N, H10
[34452671]
This is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1719045-2013-00234 |
| MDR Report Key | 2937316 |
| Report Source | 05,07 |
| Date Received | 2013-01-31 |
| Date of Report | 2013-01-02 |
| Date of Event | 2012-12-31 |
| Date Mfgr Received | 2014-04-29 |
| Device Manufacturer Date | 2012-01-20 |
| Date Added to Maude | 2013-04-17 |
| 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 | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Manufacturer G1 | SYNTHES MONUMENT |
| Manufacturer Street | 1101 SYNTHES AVE |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROBE FOR COMPARTMENTAL PRESSURE MONITORING SYSTEM |
| Generic Name | PROBE |
| Product Code | LXC |
| Date Received | 2013-01-31 |
| Returned To Mfg | 2013-01-17 |
| Catalog Number | 530.412 |
| Lot Number | US-24-1560 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES MONUMENT |
| Manufacturer Address | 1101 SYNTHES AVE MONUMENT CO 80132 US 80132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-01-31 |