MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-22 for UNK - DISTRACTOR PINS manufactured by Wrights Lane Synthes Usa Products Llc.
[188353952]
This report is for an unknown distractor pins/unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. (b)(4). Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188353953]
This report is being filed after the review of the following journal article: brown, r. Et al (2006), intracranial migration of a halo pin during distraction osteogenesis for maxillary hypoplasia: case report and literature review, journal of oral and maxillofacial surgery, vol. 64 (1), pages 130-135 (usa). This study presents a case report of a (b)(6) year-old male patient with crouzon? S syndrome who underwent a le fort iii osteotomy for distraction osteogenesis using rigid external distractor. Postoperatively, the patient developed pneumonia that required intravenous (iv) antibiotics but was subsequently discharged home. After approximately 30 days of distraction, 25 mm of advancement of the maxilla at the anterior nasal spine was achieved, and the distraction was discontinued. Although the patient complained of facial pain with distraction, there were no signs of pin infection or loosening throughout the course. The only complications he experienced were a broken wire that was easily replaced. The device was left in position another 6 weeks to allow consolidation of the regenerate. After 2. 5 months the patient was taken back to the operating room to have the device removed. During removal, it was noticed that the distractor appeared to have shifted to the patient? S right side, and there was bunching of the soft tissues in the right parietal scalp. The right posterior pin appeared to penetrate the skull, and as such, neurosurgery was called into the operating room for evaluation. After enlarging the incision here, a small defect in the dura was found exposing brain and creating a small cerebrospinal fluid (csf) leak. This was thoroughly irrigated and debrided, hemostasis achieved, and the defect covered with a local pericranial flap. There was no sign of infection. The soft tissues were closed, and the patient was immediately evaluated for possible intracranial injury by computed tomography (ct) scan. The ct revealed only bitemporal soft tissue swelling and small bony defects in both the left and right parietal regions with no signs of intracranial hemorrhage or brain injury. The defect on the left was not previously appreciated clinically. Following the scan, the patient was admitted to the hospital for iv antibiotics. He had a fever on the first postoperative night, but this resolved, and he had an otherwise uneventful recovery. He was discharged home on postoperative day 5 in good condition. This report is for an unknown synthes distractor pins. It captures reported penetration to the skull, csf leak, and bitemporal soft tissue swelling, small bony defects in both the left and right parietal regions. This is report 2 of 4 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-00351 |
| MDR Report Key | 9618194 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-22 |
| Date of Report | 2020-01-03 |
| Date Mfgr Received | 2020-01-03 |
| Date Added to Maude | 2020-01-22 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK - DISTRACTOR PINS |
| Generic Name | MANDIBLE DISTRACTION DEVICES |
| Product Code | MQN |
| Date Received | 2020-01-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHTS LANE SYNTHES USA PRODUCTS LLC |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-22 |