MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-01 for KLS MARTIN INDIVIDUAL PATIENT SOLUTIONS (IPS) manufactured by Kls-martin L.p..
[143683204]
A set of kls martin custom oral splints used during craniofacial procedures did not seem to tolerate the sterilization process as intended. The splints appeared to melt and crack, rendering them unusable. This led to operating room case delays and use of an alternative, less-preferred method for cleaning of a second back-up set of splints. This has happened several times with the kls splints which may be too thin to tolerate the sterilization parameters recommended in the instructions for use. This has the potential to place patients at risk for infection or delayed surgery. We have asked the vendor to provide the splints a week ahead of time vs. The day before surgery, to avoid last minute splint defects related to sterilization. The splints were peel-packed and sterilized at 270f degrees (average load temp 272. 8), for 4 minutes, 30 minute dry time. This has happened on several occasions with children undergoing craniofacial surgeries where splints are used. Manufacturer response for custom orthognatic splints for craniofacial surgery (per site reporter). The manufacturer is actively trying to assess why the defect is occurring.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8568524 |
| MDR Report Key | 8568524 |
| Date Received | 2019-05-01 |
| Date of Report | 2019-04-18 |
| Date of Event | 2019-03-26 |
| Report Date | 2019-04-18 |
| Date Reported to FDA | 2019-04-18 |
| Date Reported to Mfgr | 2019-05-01 |
| Date Added to Maude | 2019-05-01 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KLS MARTIN INDIVIDUAL PATIENT SOLUTIONS (IPS) |
| Generic Name | POSITIONER, TOOTH, PREFORMED |
| Product Code | KMY |
| Date Received | 2019-05-01 |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KLS-MARTIN L.P. |
| Manufacturer Address | 11228 SAINT JOHNS INDUSTRIAL PARKWAY SOUTH JACKSONVILLE FL 32246 US 32246 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-01 |