MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-26 for UNKNOWN_FRO_PRODUCT UNK_FRO manufactured by Stryker Leibinger Freiburg.
[184441247]
Device is not available for evaluation. If additional information is received it will be reported on a supplemental report. Device unable to be returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[184441248]
It was reported by the company representative that during the first pmd2 case, the left distractor locking mechanism got stuck halfway between lock and unlocked. When the surgeon went to distract the mandible on post-operation, the left distractor was stuck. During the second planned procedure, the surgeon found that the distractor was again stuck between lock and unlocked. He clicked the distractor into the unlock position and then back into the locked position. The distractor then operated normally.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008010177-2020-00010 |
| MDR Report Key | 9758336 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-01-29 |
| Date Mfgr Received | 2020-02-04 |
| Date Added to Maude | 2020-02-26 |
| 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 | MR. KELLI DYKSTRA |
| Manufacturer Street | BOETZINGERSTR. 41 |
| Manufacturer City | FREIBURG D-79111 |
| Manufacturer Country | DE |
| Manufacturer Postal | D-79111 |
| Manufacturer Phone | 76145120 |
| Manufacturer G1 | STRYKER LEIBINGER FREIBURG |
| Manufacturer Street | BOETZINGERSTR. 41 |
| Manufacturer City | FREIBURG D-79111 |
| Manufacturer Country | DE |
| Manufacturer Postal Code | D-79111 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN_FRO_PRODUCT |
| Generic Name | DISTRACTOR |
| Product Code | MQN |
| Date Received | 2020-02-26 |
| Catalog Number | UNK_FRO |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER LEIBINGER FREIBURG |
| Manufacturer Address | BOETZINGERSTR. 41 FREIBURG D-79111 DE D-79111 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-26 |